21 C.F.R. § 890.3880 Special grade wheelchair.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 890—PHYSICAL MEDICINE DEVICES
Subpart D—Physical Medicine Prosthetic Devices
§ 890.3880 Special grade wheelchair.