21 C.F.R. Subpart D—Physical Medicine Prosthetic Devices
Title 21 - Food and Drugs
(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 of this chapter, subject to the limitations in §890.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001] (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 of this chapter, subject to the limitations in §890.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001] (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 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 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §890.9. [48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38816, July 25, 2001] (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). (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 of this chapter, subject to the limitations in §890.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001] (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 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §890.9. [48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38816, July 25, 2001] (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 of this chapter, subject to the limitations in §890.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001] (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 of this chapter, subject to the limitations in §890.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001] (a) Identification. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or 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 of this chapter, subject to the limitations in §890.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001] (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 procedures in subpart E of part 807 of this chapter, subject to the limitations in §890.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001] (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 §890.9. [48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998] (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). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §890.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001] (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] (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 of this chapter, subject to the limitations in §890.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001] (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 of this chapter, subject to the limitations in §890.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001] (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 of this chapter, subject to the limitations in §890.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001] (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). (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 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §890.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 54 FR 25052, June 12, 1989; 66 FR 38817, July 25, 2001] (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 §890.9. [48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998] (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. (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 §890.9. [48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998] (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 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §890.9. [48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38817, July 25, 2001] (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 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §890.9. [48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38817, July 25, 2001] (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 of this chapter, subject to the limitations in §890.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001] (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). (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 of this chapter, subject to the limitations in §890.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001] (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). (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). (a) Identification. A special grade wheelchair is a device with wheels that 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). (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. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 12, 2000, for any stair-climbing wheelchair that was in commercial distribution before May 28, 1976, or that has, on or before July 12, 2000, been found to be substantially equivalent to a stair-climbing wheelchair that was in commercial distribution before May 28, 1976. Any other stair-climbing wheelchair shall have an approved PMA or 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; 52 FR 22577, June 12, 1987; 65 FR 19834, Apr. 13, 2000] (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). (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 §880.6760 of this chapter, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §890.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records, and §820.198, regarding complaint files. [61 FR 8439, Mar. 4, 1996, as amended at 66 FR 38817, July 25, 2001] (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 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §890.9. [48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38817, July 25, 2001] (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). (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 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §890.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38817, July 25, 2001]
Title 21: Food and Drugs
PART 890—PHYSICAL MEDICINE DEVICES
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.
