510(k) K954272

INNOVA RECTAL STIMULATON ELECTRODE by Empi — Product Code KPI

K954272 is an FDA 510(k) premarket notification submitted by Empi for the device "INNOVA RECTAL STIMULATON ELECTRODE". The FDA issued a decision of Substantially Equivalent on April 15, 1996. 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.