MARK VII THERMOREGULATION ASSIST SYSTEM

MARK VII THERMOREGULATION ASSIST SYSTEM is an FDA 510(k)-cleared medical device (K900355) manufactured by Life Enhancement Technologies, LLC. 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 14, 1990. Regulation: 8.