Panels › Gastroenterology, Urology › Product code KPI · Class 2
Stimulator, Electrical, Non-Implantable, For Incontinence
Regulation 876.5320
7510(k)s in 12 months (97 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KPI
| Company | 510(k)s | Recalls |
|---|---|---|
| Hollister, Inc. | 10 | 0 |
| Empi | 8 | 0 |
| Incontrol Medical, LLC | 7 | 0 |
| BTL Industries, Inc. | 4 | 0 |
| The Prometheus Group | 4 | 0 |
| Shenzhen Konmed Technology Co., Ltd. | 4 | 0 |
| Tenscare, Ltd. | 4 | 0 |
| Utah Medical Products, Inc. | 4 | 0 |
| Athena Feminine Technologies, Inc. | 2 | 0 |
| Everyway Medical Instruments Co.,Ltd | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 23, 2026 | K262353 | BTL-299-F BTL Industries, Inc. | KPI |
| Jun 18, 2026 | K260178 | Pelvic Muscle Trainer (KM510, KM516B) Shenzhen Konmed Technology Co., Ltd., CN | KPI |
| May 14, 2026 | K252601 | Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC Hunan Accurate Bio-Medical Technology Co., Ltd., CN | KPI |
| May 6, 2026 | K252552 | Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) Shenzhen Changkun Technology Co., Ltd., CN | KPI |
| Apr 28, 2026 | K252831 | Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) Dolanvy (Suzhou) Medical Technology Co., Ltd., CN | KPI |
| Apr 17, 2026 | K252334 | PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) Pontemedag, CH | KPI |
| Feb 12, 2026 | K251760 | Well-Life Incontinence Stimulation System (WL-2405i(P)) Well-Life Healthcare , Ltd., TW | KPI |
| Aug 29, 2025 | K251026 | Regenesis EMS Chair Trinity Medical Solutions | KPI |
| Jun 26, 2025 | K243079 | NeuroTrac® MyoPlus Pro (MYO120U) Verity Medical , Ltd., IE | KPI |
| Mar 27, 2025 | K241862 | Levina Pelvic Floor Muscle Stimulator (RS-48) Zmi Electronics , Ltd., TW | KPI |
| Feb 10, 2025 | K241516 | BTL-398 BTL Industries, Inc. | KPI |
| Nov 27, 2024 | K241899 | Pelvic Floor Stimulator (Intrelief PFE) Easymed Instruments Co., Ltd., CN | KPI |
| Jul 1, 2024 | K234061 | StarFormer Fotona D.O.O., SI | KPI |
| Feb 23, 2024 | K233576 | Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: Shenzhen Konmed Technology Co., Ltd., CN | KPI |
| Jan 18, 2024 | K231166 | Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes Zmi Electronics , Ltd., TW | KPI |
| Oct 20, 2023 | K230983 | Unicare (K-UNICARE-USA) Tenscare, Ltd., GB | KPI |
| Oct 5, 2023 | K230780 | MFG-05 Zimmer Medizinsysteme GmbH, DE | KPI |
| Sep 21, 2023 | K230767 | Pelvic Floor Muscle Stimulator Nanjing Vishee Medical Technology Co., Ltd., CN | KPI |
| Dec 29, 2022 | K222528 | Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Healthcare Limited, TW | KPI |
| Jul 20, 2022 | K220161 | Biofeedback Nerve and Muscle Stimulator Shenzhen Konmed Technology Co., Ltd., CN | KPI |
| Apr 13, 2022 | K213133 | Keffort (MC-100, MC-100A) Oriental Inspiration Limited, CN | KPI |
| Dec 3, 2021 | K213116 | Everyway Incontinence Stimulation System Everyway Medical Instruments Co.,Ltd, CN | KPI |
| Sep 17, 2021 | K210441 | Incontinence Probe Shenzhen Med-Link Electronics Tech Co., Ltd., CN | KPI |
| Jan 13, 2021 | K201014 | MyOnyx System Thought Technology , Ltd., CA | KPI |
| May 5, 2020 | K200293 | InMode System with vTone Applicator InMode , Ltd., IL | KPI |
| Nov 1, 2019 | K191312 | Perfect PFE Tenscare, Ltd., GB | KPI |
| Mar 15, 2019 | K182022 | ApexMV Incontrol Medical, LLC | KPI |
| Nov 14, 2018 | K181497 | HPM-6000UF BTL Industries, Inc. | KPI |
| Mar 15, 2018 | K171430 | Incontinence Treatment Device, Model LT2061 Shenzhen Dongdixin Technology Co., Ltd., CN | KPI |
| Jan 18, 2018 | K163288 | Pelvifine Pelvic Muscle Trainer Shenzhen Konmed Technology Co., Ltd., CN | KPI |
| Jul 7, 2017 | K161349 | Everyway Incontinence Stimulation System Everyway Medical Instrument Co., Ltd., CN | KPI |
| Dec 13, 2016 | K162010 | HPM-6000U BTL Industries, Inc. | KPI |
| Jul 12, 2016 | K161055 | Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ Fuji Dynamics , Ltd., CN | KPI |
| May 4, 2016 | K160773 | Yarlap II International Trade Group, Inc. | KPI |
| Jun 17, 2015 | K142369 | Urinary Incontinence System Guangzhou Finecure Medical Equipment Co.,Ltd, CN | KPI |
| Apr 24, 2015 | K141643 | YARLAP International Trade Group, Inc. | KPI |
| Apr 20, 2015 | K142506 | TensCare KegelFit Tenscare, Ltd., GB | KPI |
| Apr 9, 2015 | K150183 | ApexM Incontrol Medical, LLC | KPI |
| Mar 16, 2015 | K150180 | InTone Incontrol Medical, LLC | KPI |
| Jan 23, 2015 | K140265 | ELECTRODE FOR URINARY INCONTINENCE Guangzhou Finecure Medical Equipment Co.,Ltd, CN | KPI |
| Nov 26, 2014 | K141158 | APEX Incontrol Medical, LLC | KPI |
| Feb 25, 2014 | K134020 | INTONEMV Incontrol Medical, LLC | KPI |
| Jan 6, 2014 | K133826 | INTONEMV Incontrol Medical, LLC | KPI |
| Apr 4, 2013 | K122194 | LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE Everyway Medical Instruments Co.,Ltd, TW | KPI |
| Aug 24, 2012 | K121820 | INWAVE Zynex Medical, Inc. | KPI |
| Feb 22, 2012 | K110179 | INCONTROL Incontrol Medical, LLC | KPI |
| Jun 21, 2011 | K103698 | TENSCARE ITOUCH SURE MODEL ITS Tenscare, Ltd., GB | KPI |
| Dec 4, 2009 | K093600 | OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM Accelerated Care Plus | KPI |
| Jul 14, 2009 | K083704 | NUTRAC PELVATOR, MODEL PEL 200 Verity Scientific , Ltd. | KPI |
| Sep 12, 2008 | K081480 | KEGEL8 PELVIC EXERCISER, MODEL OPH 400 Ne Services , Ltd. | KPI |
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