DENOVO TEDDY GEL INFANT HEEL WARMER

DENOVO TEDDY GEL INFANT HEEL WARMER is an FDA 510(k)-cleared medical device (K103549) manufactured by Denovo Products, LLC. This device is classified under the Physical Medicine specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 7, 2011. Regulation: 8.