{"data":{"id":"us/21-cfr-890.3500","jurisdiction":"us","citation":"21 CFR 890.3500","heading":"External assembled lower limb prosthesis.","body":"(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 890—PHYSICAL MEDICINE DEVICES","Subpart D—Physical Medicine Prosthetic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"ccf56b24224e9134f3ce5567853c87384c4ff6c99d78a0517036a5dd921b3f27","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-890.3490","next":"us/21-cfr-890.3520"},"notice":"GroundRules: Original legal text. Not legal advice."}