CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001

CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001 is an FDA 510(k)-cleared medical device (K991684) manufactured by Thermogear, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 29, 2000. Regulation: 8.