INCARE HOT/ICE LITE MACHINE

INCARE HOT/ICE LITE MACHINE is an FDA 510(k)-cleared medical device (K962537) 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 November 26, 1996. Regulation: 8.