CushionCast Moldable Cushions

CushionCast Moldable Cushions is an FDA 510(k)-cleared medical device (K162265) manufactured by Izi Medical Products, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 14, 2016. Regulation: 8.