CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 890—PHYSICAL MEDICINE DEVICES > SUBPART D—Physical Medicine Prosthetic Devices (§890.3025 to §890.3940) > 890.3500—External assembled lower limb prosthesis.

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.

Code of Federal Regulations

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]