INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)

INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES) is an FDA 510(k)-cleared medical device (K964006) manufactured by Hollister, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 30, 1996. Regulation: 8.