HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET

HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET is an FDA 510(k)-cleared medical device (K963099) manufactured by Heelbo, Inc.. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 31, 1996. Regulation: 8.