510(k) K945292

TS-700P CONTROL XP ELECTRICAL STIMULATOR by Myo/Kinetic Systems, Inc. — Product Code KPI

K945292 is an FDA 510(k) premarket notification submitted by Myo/Kinetic Systems, Inc. for the device "TS-700P CONTROL XP ELECTRICAL STIMULATOR". The FDA issued a decision of Substantially Equivalent on April 12, 1995. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Myo/Kinetic Systems, Inc. has at least 7 other 510(k) clearances on record.