
Breg, Inc.
Free shipping on orders over $99 · 30-day returns
MODIFICATION TO POLAR CARE 500 is an FDA 510(k)-cleared medical device (K070402) 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 March 28, 2007. Regulation: 8.