BUTTERFLY TONER MODEL GYM070

BUTTERFLY TONER MODEL GYM070 is an FDA 510(k)-cleared medical device (K093368) manufactured by Global Marketing Partners Dba Gymmax USA. 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 January 26, 2010. Regulation: 8.