TEMPTEK T-1000 THERAPEUTIC COOLING UNIT

TEMPTEK T-1000 THERAPEUTIC COOLING UNIT is an FDA 510(k)-cleared medical device (K891091) manufactured by Temptek, Inc.. 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 March 25, 1990. Regulation: 8.