HOT/ICE DUAL FUNCTION EQUIPMENT

HOT/ICE DUAL FUNCTION EQUIPMENT is an FDA 510(k)-cleared medical device (K871962) manufactured by Thermo Temp, 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 June 25, 1987. Regulation: 8.