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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Aug 30, 2024.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR890.3610]
See Related Information on Rigid pneumatic structure orthosis. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 890 -- PHYSICAL MEDICINE DEVICES

Subpart D - Physical Medicine Prosthetic Devices

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]

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