(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]