Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)

Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) is an FDA 510(k)-cleared medical device (K151845) manufactured by CooperSurgical, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 17, 2016. Regulation: 8.