POWERED LOW AIR LOSS MATTRESS SYSTEM

POWERED LOW AIR LOSS MATTRESS SYSTEM is an FDA 510(k)-cleared medical device (K961159) manufactured by Span-America Medical Systems, 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 June 13, 1996. Regulation: 8.