GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE)

GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE) is an FDA 510(k)-cleared medical device (K051278) manufactured by Rg Ent., 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 June 28, 2006. Regulation: 8.