INCARE HOT/ICE SYSTEM 3

INCARE HOT/ICE SYSTEM 3 is an FDA 510(k)-cleared medical device (K915196) 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 February 2, 1992. Regulation: 8.