Cadwell Sierra Summit, Cadwell Sierra Ascent

Cadwell Sierra Summit, Cadwell Sierra Ascent is an FDA 510(k)-cleared medical device (K162383) manufactured by Cadwell Industries, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 28, 2017. Regulation: 8.