NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS

NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS is an FDA 510(k)-cleared medical device (K061866) manufactured by Thermotek, 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 August 21, 2006. Regulation: 8.