§890.3500. External assembled lower limb prosthesis.
21 C.F.R. § 890.3500
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.
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.
Notes, amendments, and revision history
Amendments
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted.
Amendments
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]