PRN THERMALCARE, MODEL 3000

PRN THERMALCARE, MODEL 3000 is an FDA 510(k)-cleared medical device (K062794) manufactured by American Healthcare Products, 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 December 6, 2006. Regulation: 8.