21 C.F.R. § 890.3500 External assembled lower limb prosthesis.
Title 21 - Food and Drugs
(a) Identification. An external assembled lower limb prosthesis is a device that is intended for medical purposes and is a preassembled external artificial limb for the lower extremity. Examples of external assembled lower limb prostheses are the following: Knee/shank/ankle/foot assembly and thigh/knee/shank/ankle/foot assembly. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §890.9. [48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]
Title 21: Food and Drugs
PART 890—PHYSICAL MEDICINE DEVICES
Subpart D—Physical Medicine Prosthetic Devices
§ 890.3500 External assembled lower limb prosthesis.
