INCARE HOT/ICE COLD THERAPY COOLER

INCARE HOT/ICE COLD THERAPY COOLER is an FDA 510(k)-cleared medical device (K944971) manufactured by Hollister, 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 January 29, 1995. Regulation: 8.