THERMOAIRE SPLINT (TM) (TAS)

THERMOAIRE SPLINT (TM) (TAS) is an FDA 510(k)-cleared medical device (K900356) manufactured by Life Enhancement Technologies, LLC. 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 May 6, 1990. Regulation: 8.