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Code of Federal Regulations Title 21. Food and Drugs § 21.890.3500 External assembled lower limb prosthesis

Current as of January 02, 2025 | Updated by Findlaw Staff

(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.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.890.3500 External assembled lower limb prosthesis - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-890-3500/

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