CRANIAL REMOLDING ORTHOSIS

CRANIAL REMOLDING ORTHOSIS is an FDA 510(k)-cleared medical device (K111247) manufactured by Orthotic Care Services, Llp. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 14, 2011. Regulation: 8.