510(k) K001903

NEOCONTROL PELVIC FLOOR THERAPY SYSTEM by Neotonus, Inc. — Product Code KPI

K001903 is an FDA 510(k) premarket notification submitted by Neotonus, Inc. for the device "NEOCONTROL PELVIC FLOOR THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on August 29, 2000. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Neotonus, Inc. has at least 3 other 510(k) clearances on record.