Stimulator, Electrical, Non-Implantable, For Incontinence
FDA product code KPI · Class II (moderate risk) · 21 CFR 876.5320 · Gastroenterology, Urology
96510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Hollister, Inc. 10
- Empi 8
- Incontrol Medical, LLC 7
- Tenscare, Ltd. 4
- Shenzhen Konmed Technology Co., Ltd. 4
- Utah Medical Products, Inc. 4
- The Prometheus Group 4
- BTL Industries, Inc. 3
- Laborie Medical Technologies, Ltd. 2
- Athena Feminine Technologies, Inc. 2
- Everyway Medical Instruments Co.,Ltd 2
- Laborie Medical Tech Corp. 2
- Neotonus, Inc. 2
- Zmi Electronics , Ltd. 2
- Guangzhou Finecure Medical Equipment Co.,Ltd 2
- Well-Life Healthcare Limited 2
- International Trade Group, Inc. 2
- Thought Technology , Ltd. 2
- Hunan Accurate Bio-Medical Technology Co., Ltd. 1
- Tridak Division of Indicon, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260178 | Pelvic Muscle Trainer (KM510, KM516B)KPI · Traditional | Shenzhen Konmed Technology Co., Ltd. | 06/18/2026SE |
| K252601 | Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer…KPI · Traditional | Hunan Accurate Bio-Medical Technology Co., Ltd. | 05/14/2026SE |
| K252552 | Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)KPI · Traditional | Shenzhen Changkun Technology Co., Ltd. | 05/06/2026SE |
| K252831 | Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924…KPI · Traditional | Dolanvy (Suzhou) Medical Technology Co., Ltd. | 04/28/2026SE |
| K252334 | PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)KPI · Traditional | Pontemedag | 04/17/2026SE |
| K251760 | Well-Life Incontinence Stimulation System (WL-2405i(P))KPI · Traditional | Well-Life Healthcare , Ltd. | 02/12/2026SE |
| K251026 | Regenesis EMS ChairKPI · Traditional | Trinity Medical Solutions | 08/29/2025SE |
| K243079 | NeuroTrac® MyoPlus Pro (MYO120U)KPI · Traditional | Verity Medical , Ltd. | 06/26/2025SE |
| K241862 | Levina Pelvic Floor Muscle Stimulator (RS-48)KPI · Traditional | Zmi Electronics , Ltd. | 03/27/2025SE |
| K241516 | BTL-398KPI · Traditional | BTL Industries, Inc. | 02/10/2025SE |
| K241899 | Pelvic Floor Stimulator (Intrelief PFE)KPI · Traditional | Easymed Instruments Co., Ltd. | 11/27/2024SE |
| K234061 | StarFormerKPI · Traditional | Fotona D.O.O. | 07/01/2024SE |
| K233576 | Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505…KPI · Traditional | Shenzhen Konmed Technology Co., Ltd. | 02/23/2024SE |
| K231166 | Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe…KPI · Traditional | Zmi Electronics , Ltd. | 01/18/2024SE |
| K230983 | Unicare (K-UNICARE-USA)KPI · Traditional | Tenscare, Ltd. | 10/20/2023SE |
| K230780 | MFG-05KPI · Traditional | Zimmer Medizinsysteme GmbH | 10/05/2023SE |
| K230767 | Pelvic Floor Muscle StimulatorKPI · Traditional | Nanjing Vishee Medical Technology Co., Ltd. | 09/21/2023SE |
| K222528 | Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence…KPI · Traditional | Well-Life Healthcare Limited | 12/29/2022SE |
| K220161 | Biofeedback Nerve and Muscle StimulatorKPI · Traditional | Shenzhen Konmed Technology Co., Ltd. | 07/20/2022SE |
| K213133 | Keffort (MC-100, MC-100A)KPI · Traditional | Oriental Inspiration Limited | 04/13/2022SE |
| K213116 | Everyway Incontinence Stimulation SystemKPI · Traditional | Everyway Medical Instruments Co.,Ltd | 12/03/2021SE |
| K210441 | Incontinence ProbeKPI · Traditional | Shenzhen Med-Link Electronics Tech Co., Ltd. | 09/17/2021SE |
| K201014 | MyOnyx SystemKPI · Traditional | Thought Technology , Ltd. | 01/13/2021SE |
| K200293 | InMode System with vTone ApplicatorKPI · Traditional | InMode , Ltd. | 05/05/2020SE |
| K191312 | Perfect PFEKPI · Traditional | Tenscare, Ltd. | 11/01/2019SE |
| K182022 | ApexMVKPI · Traditional | Incontrol Medical, LLC | 03/15/2019SESK |
| K181497 | HPM-6000UFKPI · Traditional | BTL Industries, Inc. | 11/14/2018SE |
| K171430 | Incontinence Treatment Device, Model LT2061KPI · Traditional | Shenzhen Dongdixin Technology Co., Ltd. | 03/15/2018SE |
| K163288 | Pelvifine Pelvic Muscle TrainerKPI · Traditional | Shenzhen Konmed Technology Co., Ltd. | 01/18/2018SE |
| K161349 | Everyway Incontinence Stimulation SystemKPI · Traditional | Everyway Medical Instrument Co., Ltd. | 07/07/2017SE |
| K162010 | HPM-6000UKPI · Traditional | BTL Industries, Inc. | 12/13/2016SE |
| K161055 | Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji 01/ 02/ 03/ 04/ 05/ 06/…KPI · Traditional | Fuji Dynamics , Ltd. | 07/12/2016SE |
| K160773 | Yarlap IIKPI · Traditional | International Trade Group, Inc. | 05/04/2016SE |
| K142369 | Urinary Incontinence SystemKPI · Traditional | Guangzhou Finecure Medical Equipment Co.,Ltd | 06/17/2015SE |
| K141643 | YarlapKPI · Traditional | International Trade Group, Inc. | 04/24/2015SE |
| K142506 | TensCare KegelFitKPI · Traditional | Tenscare, Ltd. | 04/20/2015SE |
| K150183 | ApexMKPI · Traditional | Incontrol Medical, LLC | 04/09/2015SE |
| K150180 | InToneKPI · Traditional | Incontrol Medical, LLC | 03/16/2015SE |
| K140265 | Electrode for Urinary IncontinenceKPI · Traditional | Guangzhou Finecure Medical Equipment Co.,Ltd | 01/23/2015SE |
| K141158 | ApexKPI · Traditional | Incontrol Medical, LLC | 11/26/2014SE |
| K134020 | IntonemvKPI · Traditional | Incontrol Medical, LLC | 02/25/2014SE |
| K133826 | IntonemvKPI · Special | Incontrol Medical, LLC | 01/06/2014SE |
| K122194 | Life-Care Vaginal Probe Life-Care Anal ProbeKPI · Traditional | Everyway Medical Instruments Co.,Ltd | 04/04/2013SE |
| K121820 | InwaveKPI · Abbreviated | Zynex Medical, Inc. | 08/24/2012SE |
| K110179 | IncontrolKPI · Traditional | Incontrol Medical, LLC | 02/22/2012SE |
| K103698 | Tenscare Itouch Sure Model ItsKPI · Traditional | Tenscare, Ltd. | 06/21/2011SE |
| K093600 | Omnistim Continence+ Pelvic Floor Stimulation SystemKPI · Traditional | Accelerated Care Plus | 12/04/2009SE |
| K083704 | Nutrac Pelvator, Model Pel 200KPI · Traditional | Verity Scientific , Ltd. | 07/14/2009SE |
| K081480 | KEGEL8 Pelvic Exerciser, Model Oph 400KPI · Traditional | Ne Services , Ltd. | 09/12/2008SE |
| K070331 | Urostym Biofeedback and Stimulation Device and AccessoriesKPI · Traditional | Laborie Medical Technologies | 05/04/2007SE |
| K053434 | Myotrac Infiniti Electrical StimulatorKPI · Traditional | Thought Technology , Ltd. | 03/15/2006SE |
| K053007 | Skylark Uro ProbeKPI · Traditional | Skylark Device & Systems Co., Ltd. | 12/05/2005SE |
| K050483 | Evadri Bladder Control SystemsKPI · Traditional | Hollister, Inc. | 04/12/2005SE |
| K033256 | Athena Pelvic Muscle Trainer IIKPI · Abbreviated | Athena Feminine Technologies, Inc. | 12/30/2003SE |
| K032988 | Elpha 4 ContiKPI · Abbreviated | Danmeter A/S | 12/03/2003SE |
| K030039 | Pathway STM-10 Pelvic Floor StimulatorKPI · Traditional | The Prometheus Group | 05/23/2003SE |
| K023905 | Athena Pelvic Muscle TrainerKPI · Traditional | Athena Feminine Technologies, Inc. | 04/30/2003SE |
| K023906 | Pathway CTS2000 Pelvic Floor Training SystemKPI · Traditional | The Prometheus Group | 02/19/2003SE |
| K013141 | Microgyn Plus Stimulation DeviceKPI · Traditional | Hollister, Inc. | 12/19/2001SE |
| K011435 | HMT 21, HMT 2000 Urinary Incontinence SystemKPI · Traditional | Hmt, Inc. | 06/22/2001SE |
| K002154 | K.E.A.T.KPI · Traditional | Emd Electronic Medical Devices, Corp. | 03/22/2001SE |
| K001903 | Neocontrol Pelvic Floor Therapy SystemKPI · Traditional | Neotonus, Inc. | 08/29/2000SE |
| K994109 | Detrusan 500KPI · Traditional | Innovamed USA, Inc. | 08/03/2000SE |
| K001515 | Pathway CTS 2000 Pelvic Floor Training System, Model Pathway CTS 2000KPI · Traditional | The Prometheus Group | 07/31/2000SE |
| K993976 | Pathway Vaginal Emg/Stim Perineometer Sensor, Pathway Anal Emg/Stim Perineometer SensorKPI · Traditional | The Prometheus Group | 02/22/2000SE |
| K993721 | Urostym Biofeedback and Stimulation Anal/Rectal ProbesKPI · Abbreviated | Laborie Medical Tech Corp. | 11/29/1999SE |
| K990041 | Urostym Biofeedback and Stimulation ProbesKPI · Traditional | Laborie Medical Tech Corp. | 08/05/1999SE |
| K990456 | Anal 2 Electrode Stimulation/Emg Probe - W/StopKPI · Traditional | Hollister, Inc. | 03/25/1999SE |
| K983206 | Small Vaginal/Rectal ElectrodeKPI · Traditional | Empi | 11/03/1998SE |
| K973096 | Neotonus Model 1000 Muscle Stimulator SystemKPI · Traditional | Neotonus, Inc. | 06/12/1998SE |
| K974048 | Incare Pelvic Floor Therapy System with Desktop ComputerKPI · Traditional | Hollister, Inc. | 12/23/1997SE |
| K972054 | Innova Rectal Reusable Electrode/Comfortpulse Regular or Small Reusable ElectrodeKPI · Traditional | Empi | 08/14/1997SE |
| K964738 | Elpha 2000 ContiKPI · Traditional | Dan Med, Inc. | 08/14/1997SE |
| K971527 | Innosense Pelvic Floor Stimulation and Electromyography SystemKPI · Traditional | Empi | 06/30/1997SE |
| K971541 | Vaginal 2 Electrode Stimulation/Emg Probe - TamponKPI · Traditional | Hollister, Inc. | 06/25/1997SE |
| K970077 | Liberty Plus SYSTEM(PFS-300)/VAGINAL Probe, Liberty PLUS(PFS-044)KPI · Traditional | Utah Medical Products, Inc. | 05/23/1997SE |
| K962009 | UrostymKPI · Traditional | Laborie Medical Technologies, Ltd. | 05/20/1997SE |
| K970307 | Minnova Pelvic Floor Stimulation SystemKPI · Traditional | Empi | 04/22/1997SE |
| K970602 | Vaginal 2 Electrode Stimulation/Emg Probe-SmallKPI · Traditional | Hollister, Inc. | 04/15/1997SE |
| K964526 | Liberty Rectal Pelvic Floor ExerciserKPI · Traditional | Utah Medical Products, Inc. | 02/10/1997SE |
| K964577 | Innova Comfortpulse Vaginal Electrode (199204)/INNOVA Comfortpulse Small Vaginal…KPI · Traditional | Empi | 01/24/1997SE |
| K963222 | Microgyn Plus Stimulation DeviceKPI · Traditional | Hollister, Inc. | 10/23/1996SE |
| K961872 | Incare Pelvic Floor Therapy System with Desktop ComputerKPI · Traditional | Hollister, Inc. | 08/09/1996SE |
| K960496 | Liberty Lite PFS SystemKPI · Traditional | Utah Medical Products, Inc. | 06/27/1996SE |
| K954272 | Innova Rectal Stimulaton ElectrodeKPI · Traditional | Empi | 04/15/1996SE |
| K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncKPI · Traditional | Hollister, Inc. | 10/17/1995SE |
| K945292 | TS-700P Control XP Electrical StimulatorKPI · Traditional | Myo/Kinetic Systems, Inc. | 04/12/1995SE |
| K943250 | LibertyKPI · Traditional | Utah Medical Products, Inc. | 02/09/1995SE |
| K941911 | Innova Pelvic Floor Stimulation SystemKPI · Traditional | Empi | 01/20/1995SE |
| K922562 | Stimtech PFX, Catalog Number 78-8540KPI · Traditional | Stimtech Products | 10/13/1993SE |
| K910081 | TBDKPI · Traditional | Empi | 07/15/1991SE |
| K891007 | Nonimplanted Electrical Continence DeviceKPI · Traditional | Tridak Division of Indicon, Inc. | 06/07/1990SE |
| K891773 | Microgyn II Elec Stim Device Treat of Urin IncontiKPI · Traditional | Hollister, Inc. | 08/23/1989SE |
| K874867 | Catr(Tm)-H Cardiotomy HolderKPI · Traditional | Bentley Laboratories, Inc. | 02/02/1988SE |
| K850167 | }Iustim - Electronic Neuromuscular StimulatorKPI · Traditional | Urologics, Inc. | 04/09/1985SE |
| K761145 | Radioisotope Calibrator (CRCO-22NB)KPI · Traditional | G.D. Searle and Co. | 12/16/1976SE |