K6-1 DIAGNOSTIC SYSTEM VERSION 3.1

K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 is an FDA 510(k)-cleared medical device (K944134) manufactured by Myo-Tronics, 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 December 8, 1994. Regulation: 8.