21 CFR 890.3500
§ 890.3500 External assembled lower limb prosthesis.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 890.3500, § 890.3500 External assembled lower limb prosthesis, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91184
- Permanent ID
ys:prov:91184@1- SHA-256
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.