510(k) K230767

Pelvic Floor Muscle Stimulator by Nanjing Vishee Medical Technology Co., Ltd. — Product Code KPI

K230767 is an FDA 510(k) premarket notification submitted by Nanjing Vishee Medical Technology Co., Ltd. for the device "Pelvic Floor Muscle Stimulator". The FDA issued a decision of Substantially Equivalent on September 21, 2023. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Nanjing Vishee Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.