THERMOWRAP, A/K/A/, THERMAL WRAP

THERMOWRAP, A/K/A/, THERMAL WRAP is an FDA 510(k)-cleared medical device (K873254) manufactured by Family Sun Tanning. 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 December 10, 1987. Regulation: 8.