ALBA HEALTH PAS WRAP SYSTEM

ALBA HEALTH PAS WRAP SYSTEM is an FDA 510(k)-cleared medical device (K961405) manufactured by Alba-Waldensian, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 25, 1996. Regulation: 8.