BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET

BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET is an FDA 510(k)-cleared medical device (K132048) manufactured by Molnlycke Health Care Us, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 5, 2013. Regulation: 8.