510(k) K971527

INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM by Empi — Product Code KPI

K971527 is an FDA 510(k) premarket notification submitted by Empi for the device "INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 30, 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.