CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B

CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B is an FDA 510(k)-cleared medical device (K100508) manufactured by Carematix, 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 May 4, 2010. Regulation: 8.