510(k) K093600

OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM by Accelerated Care Plus — Product Code KPI

K093600 is an FDA 510(k) premarket notification submitted by Accelerated Care Plus for the device "OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM". The FDA issued a decision of Substantially Equivalent on December 4, 2009. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Accelerated Care Plus has at least 2 other 510(k) clearances on record.