21 CFR § 890.3500 - External assembled lower limb prosthesis.

---
identifier: "/us/cfr/t21/s890.3500"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 890.3500 - External assembled lower limb prosthesis."
title_number: 21
title_name: "Food and Drugs"
section_number: "890.3500"
section_name: "External assembled lower limb prosthesis."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "890"
part_name: "PHYSICAL MEDICINE DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "48 FR 53047, Nov. 23, 1983, unless otherwise noted."
cfr_part: "890"
---


# 890.3500 External assembled lower limb prosthesis.

(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]