Regulatory Information

Coapt, LLC is registered with the Food and Drug Administration of the United States Government (Registration Number: 3010605876; Owner Operator Number: 10045459) for the manufacture and supply of prosthetics and orthotics products.

The Coapt Complete Control System Gen2 has been cleared as substantially equivalent to legally marketed predicate devices as a Class II device via Section 510(k) premarket notification; K191083.