510(k) K070331

UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES by Laborie Medical Technologies — Product Code KPI

K070331 is an FDA 510(k) premarket notification submitted by Laborie Medical Technologies for the device "UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on May 4, 2007. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Laborie Medical Technologies has at least 10 other 510(k) clearances on record.