Prapela SVS hospital bassinet pad (model P01)

Prapela SVS hospital bassinet pad (model P01) is an FDA 510(k)-cleared medical device (DEN240031) manufactured by Prapela, Inc.. 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 3, 2025. Regulation: 8.