TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT

TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT is an FDA 510(k)-cleared medical device (K963731) manufactured by Enthermics Medical Systems, 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 April 21, 1997. Regulation: 8.