MODEL 1100 COLD THERAPY DEVICE

MODEL 1100 COLD THERAPY DEVICE is an FDA 510(k)-cleared medical device (K955057) manufactured by Smith and Nephew Donjoy, 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 March 7, 1996. Regulation: 8.