[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR890.3890]

[Page 485]
 
                        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. 890.3890  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. 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]