[Title 21 CFR 890]
[Code of Federal Regulations (annual edition) - April 1, 1999 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter H - MEDICAL DEVICES]
[Part 890 - PHYSICAL MEDICINE DEVICES]
[From the U.S. Government Printing Office]
21FOOD AND DRUGS81999-04-011999-04-01falsePHYSICAL MEDICINE DEVICES890PART 890FOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,MEDICAL DEVICES
PART 890--PHYSICAL MEDICINE DEVICES--Table of Contents
Subpart A--General Provisions
Sec.
890.1 Scope.
890.3 Effective dates of requirement for premarket approval.
890.9 Limitations of exemptions from section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the act).
Subpart B--Physical Medicine Diagnostic Devices
890.1175 Electrode cable.
890.1225 Chronaximeter.
890.1375 Diagnostic electromyograph.
890.1385 Diagnostic electromyograph needle electrode.
890.1450 Powered reflex hammer.
890.1575 Force-measuring platform.
890.1600 Intermittent pressure measurement system.
890.1615 Miniature pressure transducer.
890.1850 Diagnostic muscle stimulator.
890.1925 Isokinetic testing and evaluation system.
Subpart C [Reserved]
Subpart D--Physical Medicine Prosthetic Devices
890.3025 Prosthetic and orthotic accessory.
890.3075 Cane.
890.3100 Mechanical chair.
890.3110 Electric positioning chair.
890.3150 Crutch.
890.3175 Flotation cushion.
890.3410 External limb orthotic component.
890.3420 External limb prosthetic component.
890.3475 Limb orthosis.
890.3490 Truncal orthosis.
890.3500 External assembled lower limb prosthesis.
890.3520 Plinth.
890.3610 Rigid pneumatic structure orthosis.
890.3640 Arm sling.
890.3665 Congenital hip dislocation abduction splint.
890.3675 Denis Brown splint.
890.3690 Powered wheeled stretcher.
890.3700 Nonpowered communication system.
890.3710 Powered communication system.
890.3725 Powered environmental control system.
890.3750 Mechanical table.
890.3760 Powered table.
890.3790 Cane, crutch, and walker tips and pads.
890.3800 Motorized three-wheeled vehicle.
890.3825 Mechanical walker.
890.3850 Mechanical wheelchair.
890.3860 Powered wheelchair.
890.3880 Special grade wheelchair.
890.3890 Stair-climbing wheelchair.
890.3900 Standup wheelchair.
890.3910 Wheelchair accessory.
890.3920 Wheelchair component.
890.3930 Wheelchair elevator.
890.3940 Wheelchair platform scale.
Subpart E [Reserved]
Subpart F--Physical Medicine Therapeutic Devices
890.5050 Daily activity assist device.
890.5100 Immersion hydrobath.
890.5110 Paraffin bath.
890.5125 Nonpowered sitz bath.
890.5150 Powered patient transport.
890.5160 Air-fluidized bed.
890.5170 Powered flotation therapy bed.
890.5180 Manual patient rotation bed.
890.5225 Powered patient rotation bed.
890.5250 Moist steam cabinet.
890.5275 Microwave diathermy.
890.5290 Shortwave diathermy.
890.5300 Ultrasonic diathermy.
890.5350 Exercise component.
890.5360 Measuring exercise equipment.
890.5370 Nonmeasuring exercise equipment.
[[Page 462]]
890.5380 Powered exercise equipment.
890.5410 Powered finger exerciser.
890.5500 Infrared lamp.
890.5525 Iontophoresis device.
890.5575 Powered external limb overload warning device.
890.5650 Powered inflatable tube massager.
890.5660 Therapeutic massager.
890.5700 Cold pack.
890.5710 Hot or cold disposable pack.
890.5720 Water circulating hot or cold pack.
890.5730 Moist heat pack.
890.5740 Powered heating pad.
890.5765 Pressure-applying device.
890.5850 Powered muscle stimulator.
890.5860 Ultrasound and muscle stimulator.
890.5880 Multi-function physical therapy table.
890.5900 Powered traction equipment.
890.5925 Traction accessory.
890.5940 Chilling unit.
890.5950 Powered heating unit.
890.5975 Therapeutic vibrator.
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted.
Subpart A--General Provisions
Sec. 890.1 Scope.
(a) This part sets forth the classification of physical medicine
devices intended for human use that are in commercial distribution.
(b) The identification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under part 807 may not show merely that the
device is accurately described by the section title and identification
provisions of a regulation in this part, but shall state why the device
is substantially equivalent to other devices, as required by
Sec. 807.87.
(c) To avoid duplicative listings, a physical medicine device that
has two or more types of uses (e.g., used both as a diagnostic device
and as a therapeutic device) is listed only in one subpart.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are the chapter I of title 21, unless otherwise
noted.
[52 FR 17741, May 11, 1987]
Sec. 890.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application of premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed
before the enactment date of the amendments, or a device that has been
found substantially equivalent to such a device, has an approval under
section 515 of the act FDA must promulgate a regulation under section
515(b) of the act requiring such approval, except as provided in
paragraph (b) of this section. Such a regulation under section 515(b) of
the act shall not be effective during the grace period ending on the
90th day after its promulgation or on the last day of the 30th full
calendar month after the regulation that classifies the device into
class III is effective, whichever is later. See section 501(f)(2)(B) of
the act. Accordingly, unless an effective date of the requirement for
premarket approval is shown in the regulation for a device classified
into class III in this part, the device may be commercially distributed
without FDA's issuance of an order approving a PMA or declaring
completed a PDP for the device. If FDA promulgates a regulation under
section 515(b) of the act requiring premarket approval for a device,
section 501(f)(1)(A) of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, includiing a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device
[[Page 463]]
before the device is commercially distributed unless it is reclassified.
If FDA knows that a device being commerically distributed may be a
``new'' device as defined in this section because of any new intended
use or other reasons, FDA may codify the statutory classification of the
device into class III for such new use. Accordingly, the regulation for
such a class III device states that as of the enactment date of the
amendments, May 28, 1976, the device must have an approval under section
515 of the act before commercial distribution.
[52 FR 17741, May 11, 1987]
Sec. 890.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
(a) The Food and Drug Administration's (FDA's) decision to grant an
exemption from the requirement of premarket notification (section 510(k)
of the act) for a generic type of class I device is based upon the
existing and reasonably foreseeable characteristics of commercially
distributed devices within that generic type. Because FDA cannot
anticipate every change in intended use or characteristic that could
significantly affect a device's safety or effectiveness, manufacturers
of any commercially distributed class I device for which FDA has granted
an exemption from the requirement of premarket notification must still
submit a premarket notification to FDA before introducing or delivering
for introduction into interstate commerce for commercial distribution
the device when:
(1) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(2) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976; e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(b) The exemption from the requirement of premarket notification for
a generic type of class II device applies only to those class II devices
that have existing or reasonably foreseeable characteristics of
commercially distributed devices within that generic type, or, in the
case of in vitro diagnostic devices, for which a misdiagnosis, as a
result of using the device, would not be associated with high morbidity
or mortality. A class II device for which FDA has granted an exemption
from the requirement of premarket notification must still submit a
premarket notification when:
(1) The device is intended for a use different from the intended use
of a legally marketed device in that generic type of device; e.g., the
device is intended for a different medical purpose, or the device is
intended for lay use where the former intended use was by health care
professionals only; or
(2) The modified device operates using a different fundamental
scientific technology than a legally marketed device in that generic
type of device; e.g., a surgical instrument cuts tissue with a laser
beam rather than with a sharpened metal blade, or an in vitro diagnostic
device detects or identifies infectious agents by using deoxyribonucleic
acid (DNA) probe or nucleic acid hybridization technology rather than
culture or immunoassay technology; or
(3) The device is an in vitro device that is intended:
(i) For use in the diagnosis, monitoring, or screening of neoplastic
diseases with the exception of immunohistochemical devices;
(ii) For use in screening or diagnosis of familial and acquired
genetic disorders, including inborn errors of metabolism;
(iii) For measuring an analyte that serves as a surrogate marker for
screening, diagnosis, or monitoring life-threatening diseases such as
acquired immune deficiency syndrome
[[Page 464]]
(AIDS), chronic or active hepatitis, tuberculosis, or myocardial
infarction or to monitor therapy;
(iv) For assessing the risk of cardiovascular diseases;
(v) For use in diabetes management;
(vi) For identifying or inferring the identity of a microorganism
directly from clinical material;
(vii) for detection of antibodies to microorganisms other than
immunoglobulin G (IgG) and IgG assays when the results are not
qualitative, or are used to determine immunity, or the assay is intended
for use in matrices other than serum or plasma;
(viii) For noninvasive testing; and
(ix) For near patient testing (point of care).
[54 FR 25052, June 12, 1989, as amended at 63 FR 59230, Nov. 3, 1998]
Subpart B--Physical Medicine Diagnostic Devices
Sec. 890.1175 Electrode cable.
(a) Identification. An electrode cable is a device composed of
strands of insulated electrical conductors laid together around a
central core and intended for medical purposes to connect an electrode
from a patient to a diagnostic machine.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter. The
devices are also exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994]
Sec. 890.1225 Chronaximeter.
(a) Identification. A chronaximeter is a device intended for medical
purposes to measure neuromuscular excitability by means of a strength-
duration curve that provides a basis for diagnosis and prognosis of
neurological dysfunction.
(b) Classification. Class II (performance standards).
Sec. 890.1375 Diagnostic electromyograph.
(a) Identification. A diagnostic electromyograph is a device
intended for medical purposes, such as to monitor and display the
bioelectric signals produced by muscles, to stimulate peripheral nerves,
and to monitor and display the electrical activity produced by nerves,
for the diagnosis and prognosis of neuromuscular disease.
(b) Classification. Class II (performance standards).
Sec. 890.1385 Diagnostic electromyograph needle electrode.
(a) Identification. A diagnostic electromyograph needle electrode is
a monopolar or bipolar needle intended to be inserted into muscle or
nerve tissue to sense bioelectrical signals. The device is intended for
medial purposes for use in connection with electromyography (recording
the intrinsic electrical properties of skeletal muscle).
(b) Classification. Class II (performance standards).
Sec. 890.1450 Powered reflex hammer.
(a) Identification. A powered reflex hammer is a motorized device
intended for medical purposes to elicit and determine controlled deep
tendon reflexes.
(b) Classification. Class II (performance standards).
Sec. 890.1575 Force-measuring platform.
(a) Identification. A force-measuring platform is a device intended
for medical purposes that converts pressure applied upon a planar
surface into analog mechanical or electrical signals. This device is
used to determine ground reaction force, centers of percussion, centers
of torque, and their variations in both magnitude and direction with
time.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]
[[Page 465]]
Sec. 890.1600 Intermittent pressure measurement system.
(a) Identification. An intermittent pressure measurement system is
an evaluative device intended for medical purposes, such as to measure
the actual pressure between the body surface and the supporting media.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]
Sec. 890.1615 Miniature pressure transducer.
(a) Identification. A miniature pressure transducer is a device
intended for medical purposes to measure the pressure between a device
and soft tissue by converting mechanical inputs to analog electrical
signals.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]
Sec. 890.1850 Diagnostic muscle stimulator.
(a) Identification. A diagnostic muscle stimulator is a device used
mainly with an electromyograph machine to initiate muscle activity. It
is intended for medical purposes, such as to diagnose motor nerve or
sensory neuromuscular disorders and neuromuscular function.
(b) Classification. Class II (performance standards).
Sec. 890.1925 Isokinetic testing and evaluation system.
(a) Identification. An isokinetic testing and evaluation system is a
rehabilitative exercise device intended for medical purposes, such as to
measure, evaluate, and increase the strength of muscles and the range of
motion of joints.
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59230, Nov. 3, 1998]
Subpart C [Reserved]
Subpart D--Physical Medicine Prosthetic Devices
Sec. 890.3025 Prosthetic and orthotic accessory.
(a) Identification. A prosthetic and orthotic accessory is a device
intended for medical purposes to support, protect, or aid in the use of
a cast, orthosis (brace), or prosthesis. Examples of prosthetic and
orthotic accessories include the following: A pelvic support band and
belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment
device, a postsurgical pylon, a transverse rotator, and a temporary
training splint.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. The
device also is exempt from the current good manufacturing practice
regulations in part 820, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
Sec. 890.3075 Cane.
(a) Identification. A cane is a device intended for medical purposes
that is used to provide minimal weight support while walking. Examples
of canes include the following: A standard cane, a forearm cane, and a
cane with a tripod, quad, or retractable stud on the ground end.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. The
device also is exempt from the current good manufacturing practice
regulation in part 820, with the exception of Sec. 820.180, with respect
to general requirements concerning records, and Sec. 820.198, with
respect to complaint files.
Sec. 890.3100 Mechanical chair.
(a) Identification. A mechanical chair is a manually operated device
intended for medical purposes that is used to assist a disabled person
in performing an activity that the person would otherwise find difficult
to do or be unable to
[[Page 466]]
do. Examples of mechanical chairs include the following: A chair with an
elevating seat used to raise a person from a sitting position to a
standing position and a chair with casters used by a person to move from
one place to another while sitting.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994]
Sec. 890.3110 Electric positioning chair.
(a) Identification. An electric positioning chair is a device with a
motorized positioning control that is intended for medical purposes and
that can be adjusted to various positions. The device is used to provide
stability for patients with athetosis (involuntary spasms) and to alter
postural positions.
(b) Classification. Class II (performance standards).
Sec. 890.3150 Crutch.
(a) Identification. A crutch is a device intended for medical
purposes for use by disabled persons to provide minimal to moderate
weight support while walking.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. The
device is also exempt from the current good manufacturing practice
regulations in part 820, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
Sec. 890.3175 Flotation cushion.
(a) Identification. A flotation cushion is a device intended for
medical purposes that is made of plastic, rubber, or other type of
covering, that is filled with water, air, gel, mud, or any other
substance allowing a flotation media, used on a seat to lessen the
likelihood of skin ulcers.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]
Sec. 890.3410 External limb orthotic component.
(a) Identification. An external limb orthotic component is a device
intended for medical purposes for use in conjunction with an orthosis
(brace) to increase the function of the orthosis for a patient's
particular needs. Examples of external limb orthotic components include
the following: A brace-setting twister and an external brace stirrup.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. The
device also is exempt from the current good manufacturing practice
regulations in part 820, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
Sec. 890.3420 External limb prosthetic component.
(a) Identification. An external limb prosthetic component is a
device intended for medical purposes that, when put together with other
appropriate components, constitutes a total prosthesis. Examples of
external limb prosthetic components include the following: Ankle, foot,
hip, knee, and socket components; mechanical or powered hand, hook,
wrist unit, elbow joint, and shoulder joint components; and cable and
prosthesis suction valves.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. The
device also is exempt from the current good manufacturing practice
regulations in part 820, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
Sec. 890.3475 Limb orthosis.
(a) Identification. A limb orthosis (brace) is a device intended for
medical purposes that is worn on the upper or
[[Page 467]]
lower extremities to support, to correct, or to prevent deformities or
to align body structures for functional improvement. Examples of limb
orthoses include the following: A whole limb and joint brace, a hand
splint, an elastic stocking, a knee cage, and a corrective shoe.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. The
device also is exempt from the current good manufacturing practice
regulations in part 820, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
Sec. 890.3490 Truncal orthosis.
(a) Identification. A truncal orthosis is a device intended for
medical purposes to support or to immobilize fractures, strains, or
sprains of the neck or trunk of the body. Examples of truncal orthoses
are the following: Abdominal, cervical, cervical-thoracic, lumbar,
lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and
clavicle splints.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification precedures in subpart E of part 807. The
device also is exempt from the current good manufacturing practice
regulations in part 820, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
Sec. 890.3500 External assembled lower limb prosthesis.
(a) Identification. An external assembled lower limb prosthesis is a
device that is intended for medical purposes and is a preassembled
external artificial limb for the lower extremity. Examples of external
assembled lower limb prostheses are the following: Knee/shank/ankle/foot
assembly and thigh/knee/shank/ankle/foot assembly.
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]
Sec. 890.3520 Plinth.
(a) Identification. A plinth is a flat, padded board with legs that
is intended for medical purposes. A patient is placed on the device for
treatment or examination.
(b) Classification. Class I (general controls). This device is
exempt from the premarket notification procedure in subpart E of part
807. The device is also exempt from the current good manufacturing
practice regulations in part 820, with the exception of Sec. 820.180,
with respect to general requirements concerning records and Sec. 820.198
with respect to complaint files.
Sec. 890.3610 Rigid pneumatic structure orthosis.
(a) Identification. A rigid pneumatic structure orthosis is a device
intended for medical purposes to provide whole body support by means of
a pressurized suit to help thoracic paraplegics walk.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before December 26, 1996 for any rigid
pneumatic structure orthosis that was in commercial distribution before
May 28, 1976, or that has, on or before December 26, 1996 been found to
be substantially equivalent to a rigid pneumatic structure orthosis that
was in commercial distribution before May 28, 1976. Any other rigid
pneumatic structure orthosis shall have an approved PMA or a declared
completed PDP in effect before being placed in commercial distribution.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 61
FR 50711, Sept. 27, 1996]
Sec. 890.3640 Arm sling.
(a) Identification. An arm sling is a device intended for medical
purposes to immobilize the arm, by means of a fabric band suspended from
around the neck.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. The
device also is
[[Page 468]]
exempt from the current good manufacturing practice regulations in part
820, with the exception of Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
Sec. 890.3665 Congenital hip dislocation abduction splint.
(a) Identification. A congenital hip dislocation abduction splint is
a device intended for medical purposes to stabilize the hips of a young
child with dislocated hips in an abducted position (away from the
midline).
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. The
device also is exempt from the current good manufacturing practice
regulations in part 820, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
Sec. 890.3675 Denis Brown splint.
(a) Identification. A Denis Brown splint is a device intended for
medical purposes to immobilize the foot. It is used on young children
with tibial torsion (excessive rotation of the lower leg) or club foot.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. The
device also is exempt from the current good manufacturing practice
regulations in part 820, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
Sec. 890.3690 Powered wheeled stretcher.
(a) Identification. A powered wheeled stretcher is a battery-powered
table with wheels that is intended for medical purposes for use by
patients who are unable to propel themselves independently and who must
maintain a prone or supine position for prolonged periods because of
skin ulcers or contractures (muscle contractions).
(b) Classification. Class II (performance standards).
Sec. 890.3700 Nonpowered communication system.
(a) Identification. A nonpowered communication system is a
mechanical device intended for medical purposes that is used to assist a
patient in communicating when physical impairment prevents writing,
telephone use, reading, or talking. Examples of nonpowered
communications systems include an alphabet board and a page turner.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter. The
device is also exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, regarding general requirements concerning records, and
Sec. 820.198, regarding complaint files.
[48 FR 53047, Nov. 23, 1983, as amended at 54 FR 25052, June 12, 1989]
Sec. 890.3710 Powered communication system.
(a) Identification. A powered communication system is an AC- or
battery-powered device intended for medical purposes that is used to
transmit or receive information. It is used by persons unable to use
normal communication methods because of physical impairment. Examples of
powered communication systems include the following: a specialized
typewriter, a reading machine, and a video picture and word screen.
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]
Sec. 890.3725 Powered environmental control system.
(a) Identification. A powered environmental control system is an AC-
or battery-powered device intended for medical purposes that is used by
a patient to operate an environmental control function. Examples of
environmental control functions include the following: to control room
temperature, to answer a doorbell or telephone, or to sound an alarm for
assistance.
[[Page 469]]
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]
Sec. 890.3750 Mechanical table.
(a) Identification. A mechanical table is a device intended for
medical purposes that has a flat surface that can be inclined or
adjusted to various positions. It is used by patients with circulatory,
neurological, or musculoskeletal conditions to increase tolerance to an
upright or standing position.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994]
Sec. 890.3760 Powered table.
(a) Identification. A powered table is a device intended for medical
purposes that is an electrically operated flat surface table that can be
adjusted to various positions. It is used by patients with circulatory,
neurological, or musculoskeletal conditions to increase tolerance to an
upright or standing position.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]
Sec. 890.3790 Cane, crutch, and walker tips and pads.
(a) Identification. Cane, crutch, and walker tips and pads are
rubber (or rubber substitute) device accessories intended for medical
purposes that are applied to the ground end of mobility aids to prevent
skidding or that are applied to the body contact area of the device for
comfort or as an aid in using an ambulatory assist device.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. The
device also is exempt from the current good manufacturing practice
regulations in part 820, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
Sec. 890.3800 Motorized three-wheeled vehicle.
(a) Identification. A motorized three-wheeled vehicle is a gasoline-
fueled or battery-powered device intended for medical purposes that is
used for outside transportation by disabled persons.
(b) Classification. Class II (performance standards).
Sec. 890.3825 Mechanical walker.
(a) Identification. A mechanical walker is a four-legged device with
a metal frame intended for medical purposes to provide moderate weight
support while walking. It is used by disabled persons who lack strength,
good balance, or endurance.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. The
device also is exempt from the current good manufacturing practice
regulations in part 820, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
Sec. 890.3850 Mechanical wheelchair.
(a) Identification. A mechanical wheelchair is a manually operated
device with wheels that is intended for medical purposes to provide
mobility to persons restricted to a sitting position.
(b) Classification. Class I (general controls).
Sec. 890.3860 Powered wheelchair.
(a) Identification. A powered wheelchair is a battery-operated
device with wheels that is intended for medical purposes to provide
mobility to persons restricted to a sitting position.
(b) Classification. Class II (performance standards).
Sec. 890.3880 Special grade wheelchair.
(a) Identification. A special grade wheelchair is a device with
wheels that
[[Page 470]]
is intended for medical purposes to provide mobility to persons
restricted to a sitting position. It is intended to be used in all
environments for long-term use, e.g., for paraplegics, quadraplegics,
and amputees.
(b) Classification. Class II (performance standards).
Sec. 890.3890 Stair-climbing wheelchair.
(a) Identification. A stair-climbing wheelchair is a device with
wheels that is intended for medical purposes to provide mobility to
persons restricted to a sitting position. The device is intended to
climb stairs by means of two endless belt tracks that are lowered from
under the chair and adjusted to the angle of the stairs.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See Sec. 890.3.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 52
FR 22577, June 12, 1987]
Sec. 890.3900 Standup wheelchair.
(a) Identification. A standup wheelchair is a device with wheels
that is intended for medical purposes to provide mobility to persons
restricted to a sitting position. The device incorporates an external
manually controlled mechanical system that is intended to raise a
paraplegic to an upright position by means of an elevating seat.
(b) Classification. Class II (performance standards).
Sec. 890.3910 Wheelchair accessory.
(a) Identification. A wheelchair accessory is a device intended for
medical purposes that is sold separately from a wheelchair and is
intended to meet the specific needs of a patient who uses a wheelchair.
Examples of wheelchair accessories include but are not limited to the
following: armboard, lapboard, pusher cuff, crutch and cane holder,
overhead suspension sling, head and trunk support, and blanket and leg
rest strap.
(b) Classification. Class I (general controls). If the device is not
intended for use as a protective restraint as defined in Sec. 880.6760
of this chapter, it is exempt from the premarket notification procedures
in subpart E of part 807 of this chapter, and is also exempt from
current good manufacturing practice regulations in part 820 of this
chapter, with the exception of Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
[61 FR 8439, Mar. 4, 1996]
Sec. 890.3920 Wheelchair component.
(a) Identification. A wheelchair component is a device intended for
medical purposes that is generally sold as an integral part of a
wheelchair, but may also be sold separately as a replacement part.
Examples of wheelchair components are the following: Armrest, narrowing
attachment, belt, extension brake, curb climber, cushion, antitip
device, footrest, handrim, hill holder, leg rest, heel loops, and toe
loops.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994]
Sec. 890.3930 Wheelchair elevator.
(a) Identification. A wheelchair elevator is a motorized lift device
intended for medical purposes to provide a means for a disabled person
to move a wheelchair from one level to another.
(b) Classification. Class II (performance standards).
Sec. 890.3940 Wheelchair platform scale.
(a) Identification. A wheelchair platform scale is a device with a
base designed to accommodate a wheelchair. It is intended for medical
purposes to weigh a person who is confined to a wheelchair.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter. The
device is also exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and
[[Page 471]]
Sec. 820.198, with respect to complaint files.
[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63015, Dec. 7, 1994]
Subpart E [Reserved]
Subpart F--Physical Medicine Therapeutic Devices
Sec. 890.5050 Daily activity assist device.
(a) Identification. A daily activity assist device is a modified
adaptor or utensil (e.g., a dressing, grooming, recreational activity,
transfer, eating, or homemaking aid) that is intended for medical
purposes to assist a patient to perform a specific function.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. If
the device is not labeled or otherwise represented as sterile, it also
is exempt from the current good manufacturing practice regulations in
part 820, with the exception of Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
Sec. 890.5100 Immersion hydrobath.
(a) Identification. An immersion hydrobath is a device intended for
medical purposes that consists of water agitators and that may include a
tub to be filled with water. The water temperature may be measured by a
gauge. It is used in hydrotherapy to relieve pain and itching and as an
aid in the healing process of inflamed and traumatized tissue, and it
serves as a setting for removal of contaminated tissue.
(b) Classification. Class II (performance standards).
Sec. 890.5110 Paraffin bath.
(a) Identification. A paraffin bath is a device intended for medical
purposes that consists of a tub to be filled with liquid paraffin (wax)
and maintained at an elevated temperature in which the patient's
appendages (e.g., hands or fingers) are placed to relieve pain and
stiffness.
(b) Classification. Class II (performance standards).
Sec. 890.5125 Nonpowered sitz bath.
(a) Identification. A nonpowered sitz bath is a device intended for
medical purposes that consists of a tub to be filled with water for use
in external hydrotherapy to relieve pain or pruritis and to accelerate
the healing of inflamed or traumatized tissues of the perianal and
perineal areas.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter. The
device is also exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, regarding general requirements concerning records, and
Sec. 820.198, regarding complaint files.
[48 FR 53047, Nov. 23, 1983, as amended at 54 FR 25052, June 12, 1989]
Sec. 890.5150 Powered patient transport.
(a) Identification. A powered patient transport is a motorized
device intended for medical purposes to assist transfers of patients to
and from the bath, beds, chairs, treatment modalities, transport
vehicles, and up and down flights of stairs. This generic type of device
does not include motorized threewheeled vehicles or wheelchairs.
(b) Classification. Class II (performance standards).
Sec. 890.5160 Air-fluidized bed.
(a) Identification. An air-fluidized bed is a device employing the
circulation of filtered air through ceramic spherules (small, round
ceramic objects) that is intended for medical purposes to treat or
prevent bedsores, to treat severe or extensive burns, or to aid
circulation.
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]
Sec. 890.5170 Powered flotation therapy bed.
(a) Identification. A powered flotation therapy bed is a device that
is equipped with a mattress that contains a large volume of constantly
moving water,
[[Page 472]]
air, mud, or sand. It is intended for medical purposes to treat or
prevent a patient's bedsores, to treat severe or extensive burns, or to
aid circulation. The mattress may be electrically heated.
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]
Sec. 890.5180 Manual patient rotation bed.
(a) Identification. A manual patient rotation bed is a device that
turns a patient who is restricted to a reclining position. It is
intended for medical purposes to treat or prevent bedsores, to treat
severe and extensive burns, or to aid circulation.
(b) Classification. Class I (general controls).
Sec. 890.5225 Powered patient rotation bed.
(a) Identification. A powered patient rotation bed is a device that
turns a patient who is restricted to a reclining position. It is
intended for medical purposes to treat or prevent bedsores, to treat
severe and extensive burns, urinary tract blockage, and to aid
circulation.
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]
Sec. 890.5250 Moist steam cabinet.
(a) Identification. A moist steam cabinet is a device intended for
medical purposes that delivers a flow of heated, moisturized air to a
patient in an enclosed unit. It is used to treat arthritis and fibrosis
(a formation of fibrosis tissue) and to increase local blood flow.
(b) Classification. Class II (performance standards).
Sec. 890.5275 Microwave diathermy.
(a) Microwave diathermy for use in applying therapeutic deep heat
for selected medical conditions--(1) Identification. A microwave
diathermy for use in applying therapeutic deep heat for selected medical
conditions is a device that applies to specific areas of the body
electromagnetic energy in the microwave frequency bands of 915 megahertz
to 2,450 megahertz and that is intended to generate deep heat within
body tissues for the treatment of selected medical conditions such as
relief of pain, muscle spasms, and joint contractures, but not for the
treatment of malignancies.
(2) Classification. Class II (performance standards).
(b) Microwave diathermy for all other uses--(1) Identification. A
microwave diathermy for all other uses except for the treatment of
malignancies is a device that applies to the body electromagnetic energy
in the microwave frequency bands of 915 megahertz to 2,450 megahertz and
that is intended for the treatment of medical conditions by means other
than the generation of deep heat within body tissues as described in
paragraph (a) of this section.
(2) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device described in paragraph (b)(1). See Sec. 890.3.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987]
Sec. 890.5290 Shortwave diathermy.
(a) Shortwave diathermy for use in applying therapeutic deep heat
for selected medical conditions--(1) Identification. A shortwave
diathermy for use in applying therapeutic deep heat for selected medical
conditions is a device that applies to specific areas of the body
electromagnetic energy in the radio frequency bands of 13 megahertz to
27.12 megahertz and that is intended to generate deep heat within body
tissues for the treatment of selected medical conditions such as relief
of pain, muscle spasms, and joint contractures, but not for the
treatment of malignancies.
(2) Classification. Class II (performance standards).
(b) Shortwave diathermy for all other uses--(1) Identification. A
shortwave diathermy for all other uses except for
[[Page 473]]
the treatment of malignancies is a device that applies to the body
electromagnetic energy in the radio frequency bands of 13 megahertz to
27.12 megahertz and that is intended for the treatment of medical
conditions by means other than the generation of deep heat within body
tissues as described in paragraph (a) of this section.
(2) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device described in paragraph (b)(1). See Sec. 890.3.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987]
Sec. 890.5300 Ultrasonic diathermy.
(a) Ultrasonic diathermy for use in applying therapeutic deep heat
for selected medical conditions--(1) Identification. An ultrasonic
diathermy for use in applying therapeutic deep heat for selected medical
conditions is a device that applies to specific areas of the body
ultrasonic energy at a frequency beyond 20 kilohertz and that is
intended to generate deep heat within body tissues for the treatment of
selected medical conditions such as relief of pain, muscle spasms, and
joint contractures, but not for the treatment of malignancies.
(2) Classification. Class II (performance standards).
(b) Ultrasonic diathermy for all other uses--(1) Identification. An
ultrasonic diathermy for all other uses except for the treatment of
malignancies is a device that applies to the body ultrasonic energy at a
frequency beyond 20 kilohertz and that is intended for the treatment of
medical conditions by means other than the generation of deep heat
within body tissues as described in paragraph (a) of this section.
(2) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device described in paragraph (b)(1). See Sec. 890.3.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987]
Sec. 890.5350 Exercise component.
(a) Identification. An exercise component is a device that is used
in conjunction with other forms of exercise and that is intended for
medical purposes, such as to redevelope muscles or restore motion to
joints or for use as an adjunct treatment for obesity. Examples include
weights, dumbbells, straps, and adaptive hand mitts.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. The
device also is exempt from the current good manufacturing practice
regulations in part 820, with the exemption of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
Sec. 890.5360 Measuring exercise equipment.
(a) Identification. Measuring exercise equipment consist of manual
devices intended for medical purposes, such as to redevelop muscles or
restore motion to joints or for use as an adjunct treatment for obesity.
These devices also include instrumentation, such as the pulse rate
monitor, that provide information used for physical evaluation and
physical planning purposes., Examples include a therapeutic exercise
bicycle with measuring instrumentation, a manually propelled treadmill
with measuring instrumentation, and a rowing machine with measuring
instrumentation.
(b) Classification. Class II (performance standards).
Sec. 890.5370 Nonmeasuring exercise equipment.
(a) Identification. Nonmeasuring exercise equipment consist of
devices intended for medical purposes, such as to redevelop muscles or
restore motion to joints or for use as an adjunct treatment for obesity.
Examples include a prone scooter board, parallel bars, a mechanical
treadmill, an exercise table, and a manually propelled exercise bicycle.
(b) Classification. Class I (general controls). The devices are
exempt from the premarket notification procedures in subpart E of part
807. The devices also
[[Page 474]]
are exempt from the current good manufacturing practice regulations in
part 820, with the exception of Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
Sec. 890.5380 Powered exercise equipment.
(a) Identification. Powered exercise equipment consist of powered
devices intended for medical purposes, such as to redevelop muscles or
restore motion to joints or for use as an adjunct treatment for obesity.
Examples include a powered treadmill, a powered bicycle, and powered
parallel bars.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]
Sec. 890.5410 Powered finger exerciser.
(a) Identification. A powered finger exerciser is a device intended
for medical purposes to increase flexion and the extension range of
motion of the joints of the second to the fifth fingers of the hand.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]
Sec. 890.5500 Infrared lamp.
(a) Identification. An infrared lamp is a device intended for
medical purposes that emits energy at infrared frequencies
(approximately 700 nanometers to 50,000 nanometers) to provide topical
heating.
(b) Classification. Class II (performance standards).
Sec. 890.5525 Iontophoresis device.
(a) Iontophoresis device intended for certain specified uses--(1)
Identification. An iontophoresis device is a device that is intended to
use a direct current to introduce ions of soluble salts or other drugs
into the body and induce sweating for use in the diagnosis of cystic
fibrosis or for other uses if the labeling of the drug intended for use
with the device bears adequate directions for the device's use with that
drug. When used in the diagnosis of cystic fibrosis, the sweat is
collected and its composition and weight are determined.
(2) Classification. Class II (performance standards).
(b) Iontophoresis device intended for any other purposes--(1)
Identification. An iontophoresis device is a device that is intended to
use a direct current to introduce ions of soluble salts or other drugs
into the body for medical purposes other than those specified in
paragraph (a) of this section.
(2) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device described in paragraph (b)(1). See Sec. 890.3.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987]
Sec. 890.5575 Powered external limb overload warning device.
(a) Identification. A powered external limb overload warning device
is a device intended for medical purposes to warn a patient of an
overload or an underload in the amount of pressure placed on a leg.
(b) Classification. Class II (performance standards).
Sec. 890.5650 Powered inflatable tube massager.
(a) Identification. A powered inflatable tube massager is a powered
device intended for medical purposes, such as to relieve minor muscle
aches and pains and to increase circulation. It simulates kneading and
stroking of tissues with the hands by use of an inflatable pressure
cuff.
(b) Classification. Class II (performance standards).
Sec. 890.5660 Therapeutic massager.
(a) Identification. A therapeutic massager is an electrically
powered device intended for medical purposes, such as to relieve minor
muscle aches and pains.
[[Page 475]]
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]
Sec. 890.5700 Cold pack.
(a) Identification. A cold pack is a device intended for medical
purposes that consists of a compact fabric envelope containing a
specially hydrated pliable silicate gel capable of forming to the
contour of the body and that provides cold therapy for body surfaces.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. The
device also is exempt from the current good manufacturing practice
regulations in part 820, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
Sec. 890.5710 Hot or cold disposable pack.
(a) Identification. A hot or cold disposable pack is a device
intended for medical purposes that consists of a sealed plastic bag
incorporating chemicals that, upon activation, provides hot or cold
therapy for body surfaces.
(b) Classification. Class I (general controls).
Sec. 890.5720 Water circulating hot or cold pack.
(a) Identification. A water circulating hot or cold pack is a device
intended for medical purposes that operates by pumping heated or chilled
water through a plastic bag and that provides hot or cold therapy for
body surfaces.
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]
Sec. 890.5730 Moist heat pack.
(a) Identification. A moist heat pack is a device intended for
medical purposes that consists of silica gel in a fabric container used
to retain an elevated temperature and that provides moist heat therapy
for body surfaces.
(b) Classification. Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807. The
device also is exempt from the current good manufacturing practice
regulations in part 820, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
Sec. 890.5740 Powered heating pad.
(a) Identification. A powered heating pad is an electrical device
intended for medical purposes that provides dry heat therapy for body
surfaces. It is capable of maintaining an elevated temperature during
use.
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E part 807
of this chapter subject to Sec. 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]
Sec. 890.5765 Presssure-applying device.
(a) Identification. A presssure-applying device is a device intended
for medical purposes to apply continuous pressure to the paravertebral
tissues for muscular relaxation and neuro-inhibition. It consists of a
table with an adjustable overhead weight that, in place of the
therapist's hands, presses on the back of a prone patient.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63015, Dec. 7, 1994]
Sec. 890.5850 Powered muscle stimulator.
(a) Identification. A powered muscle stimulator is an electrically
powered device intended for medical purposes that repeatedly contracts
muscles by passing electrical currents through electrodes contacting the
affected body area.
(b) Classification. Class II (performance standards).
[[Page 476]]
Sec. 890.5860 Ultrasound and muscle stimulator.
(a) Ultrasound and muscle stimulator for use in applying therapeutic
deep heat for selected medical conditions--(1) Identification. An
ultrasound and muscle stimulator for use in applying therapeutic deep
heat for selected medical conditions is a device that applies to
specific areas of the body ultrasonic energy at a frequency beyond 20
kilohertz and that is intended to generate deep heat within body tissues
for the treatment of selected medical conditions such as relief of pain,
muscle spasms, and joint contractures, but not for the treatment of
malignancies. The device also passes electrical currents through the
body area to stimulate or relax muscles.
(2) Classification. Class II (performance standards).
(b) Ultrasound and muscle stimulator for all other uses--(1)
Identification. An ultrasound and muscle stimulator for all other uses
except for the treatment of malignancies is a device that applies to the
body ultrasonic energy at a frequency beyond 20 kilohertz and applies to
the body electrical currents and that is intended for the treatment of
medical conditions by means other than the generation of deep heat
within body tissues and the stimulation or relaxation of muscles as
described in paragraph (a) of this section.
(2) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval for the device described in paragraph (b)(1). See Sec. 890.3.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987]
Sec. 890.5880 Multi-function physical therapy table.
(a) Identification. A multi-function physical therapy table is a
device intended for medical purposes that consists of a motorized table
equipped to provide patients with heat, traction, and muscle relaxation
therapy.
(b) Classification. Class II (performance standards).
Sec. 890.5900 Power traction equipment.
(a) Identification. Powered traction equipment consists of powered
devices intended for medical purposes for use in conjunction with
traction accessories, such as belts and harnesses, to exert therapeutic
pulling forces on the patient's body.
(b) Classification. Class II (performance standards).
Sec. 890.5925 Traction accessory.
(a) Identification. A traction accessory is a nonpowered accessory
device intended for medical purposes to be used with powered traction
equipment to aid in exerting therapeutic pulling forces on the patient's
body. This generic type of device includes the pulley, strap, head
halter, and pelvic belt.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter. The
device is also exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]
Sec. 890.5940 Chilling unit.
(a) Identification. A chilling unit is a refrigerative device
intended for medical purposes to chill and maintain cold packs at a
reduced temperature.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]
Sec. 890.5950 Powered heating unit.
(a) Identification. A powered heating unit is a device intended for
medical purposes that consists of an encased cabinet containing hot
water and that is intended to heat and maintain hot packs at an elevated
temperature.
[[Page 477]]
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]
Sec. 890.5975 Therapeutic vibrator.
(a) Identification. A therapeutic vibrator is an electrically
powered device intended for medical purposes that incorporates various
kinds of pads and that is held in the hand or attached to the hand or to
a table. It is intended for various uses, such as relaxing muscles and
relieving minor aches and pains.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]