TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM

TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM is an FDA 510(k)-cleared medical device (K063728) manufactured by Alfa Tech Medical Systems, Ltd.. 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 April 3, 2007. Regulation: 8.