510(k) K964577

INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205) by Empi — Product Code KPI

K964577 is an FDA 510(k) premarket notification submitted by Empi for the device "INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205)". The FDA issued a decision of Substantially Equivalent on January 24, 1997. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Empi has at least 10 other 510(k) clearances on record.