510(k) K972054

INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE by Empi — Product Code KPI

K972054 is an FDA 510(k) premarket notification submitted by Empi for the device "INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE". The FDA issued a decision of Substantially Equivalent on August 14, 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.