MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I

MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I is an FDA 510(k)-cleared medical device (K992694) manufactured by Myotronics-Noromed, 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 September 9, 1999. Regulation: 8.