Joint, Elbow, External Limb Component, Powered

FDA product code IRE · Class I (low risk) · 21 CFR 890.3420 · Physical Medicine

2510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K822632Elbow ProsthesisIRE · Traditional Hosmer Dorrance Corp.09/14/1982SE
K802642Utah Artifical ArmIRE · Traditional Motion Control, Inc.11/12/1980SE