IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II

IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II is an FDA 510(k)-cleared medical device (K070541) manufactured by Ivivi Technologies, 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 10, 2008. Regulation: 8.