KPI

Stimulator, Electrical, Non-Implantable, For Incontinence

Product code
KPI
Device name
Stimulator, Electrical, Non-Implantable, For Incontinence
Device class
Class 2
21 CFR
21 CFR 876.5320
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
17
Summaries archived here
14 (direct download)
510(k) clearances (all years, FDA)
96 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (17)

Last three years. Most recent: 2026-06-18.

NumberDecision dateApplicantDevice nameSummary
K2601782026-06-18Shenzhen Konmed Technology Co., Ltd.Pelvic Muscle Trainer (KM510, KM516B)PDF
K2526012026-05-14Hunan Accurate Bio-Medical Technology …Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer…PDF
K2525522026-05-06Shenzhen Changkun Technology Co., Ltd.Pelvic Floor Rehabilitation Therapy Device (PD2301/P…PDF
K2528312026-04-28Dolanvy (Suzhou) Medical Technology Co…Pelvic Floor Treatment Device (DLR-8920, DLR-8921, D…
K2523342026-04-17PontemedagPELVIPOWER Pelvic Functional Magnetic Stimulation (P…PDF
K2517602026-02-12Well-Life Healthcare , Ltd.Well-Life Incontinence Stimulation System (WL-2405i(…PDF
K2510262025-08-29Trinity Medical SolutionsRegenesis EMS ChairPDF
K2430792025-06-26Verity Medical , Ltd.NeuroTrac® MyoPlus Pro (MYO120U)PDF
K2418622025-03-27Zmi Electronics , Ltd.Levina Pelvic Floor Muscle Stimulator (RS-48)PDF
K2415162025-02-10BTL Industries, Inc.BTL-398PDF
K2418992024-11-27Easymed Instruments Co., Ltd.Pelvic Floor Stimulator (Intrelief PFE)
K2340612024-07-01Fotona D.O.O.StarFormerPDF
K2335762024-02-23Shenzhen Konmed Technology Co., Ltd.Konmed Incontinence Stimulation Electrode (Vaginal P…
K2311662024-01-18Zmi Electronics , Ltd.Levina, Levina Incontinence Stimulation Electrodes (…PDF
K2309832023-10-20Tenscare, Ltd.Unicare (K-UNICARE-USA)PDF
K2307802023-10-05Zimmer Medizinsysteme GmbHMFG-05PDF
K2307672023-09-21Nanjing Vishee Medical Technology Co.,…Pelvic Floor Muscle StimulatorPDF

14 summaries are archived here for direct download.

Official FDA classification page: KPI
Classification and pathway per current FDA publications. Data from openFDA (CC0).