FLEXWARMER, MODELS KZ-1 AND KZ-2

FLEXWARMER, MODELS KZ-1 AND KZ-2 is an FDA 510(k)-cleared medical device (K062644) manufactured by Merlyn Associates, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 10, 2007. Regulation: 8.