[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR890.3610]

[Page 502]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 890--PHYSICAL MEDICINE DEVICES--Table of Contents
 
             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]