9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS

9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS is an FDA 510(k)-cleared medical device (K963626) manufactured by 9th Wave, 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 November 25, 1996. Regulation: 8.