CUDDLE HEART -AUDITORY/VIBRATION DEVICE

CUDDLE HEART -AUDITORY/VIBRATION DEVICE is an FDA 510(k)-cleared medical device (K845002) manufactured by International Purchasing Services. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 22, 1986. Regulation: 8.