POLAR CARE (MODEL 500/50000)

POLAR CARE (MODEL 500/50000) is an FDA 510(k)-cleared medical device (K961855) manufactured by Breg, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 8, 1996. Regulation: 8.