510(k) K070541

IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II by Ivivi Technologies, Inc. — Product Code ILX

K070541 is an FDA 510(k) premarket notification submitted by Ivivi Technologies, Inc. for the device "IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II". The FDA issued a decision of Substantially Equivalent on December 11, 2008. The device falls under product code ILX (Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5290.