FDA 510(k) Applications for Medical Device Product Code "KPI"
(Stimulator, Electrical, Non-Implantable, For Incontinence)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K093600 | ACCELERATED CARE PLUS | OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM | 12/04/2009 |
| K023905 | ATHENA FEMININE TECHNOLOGIES, INC. | ATHENA PELVIC MUSCLE TRAINER | 04/30/2003 |
| K033256 | ATHENA FEMININE TECHNOLOGIES, INC. | ATHENA PELVIC MUSCLE TRAINER II | 12/30/2003 |
| K241516 | BTL Industries, Inc. | BTL-398 | 02/10/2025 |
| K162010 | BTL Industries, Inc. | HPM-6000U | 12/13/2016 |
| K181497 | BTL Industries, Inc. | HPM-6000UF | 11/14/2018 |
| K964738 | DAN MED, INC. | ELPHA 2000 CONTI | 08/14/1997 |
| K032988 | DANMETER A/S | ELPHA 4 CONTI | 12/03/2003 |
| K241899 | EasyMed Instruments Co., Ltd. | Pelvic Floor Stimulator (Intrelief PFE) | 11/27/2024 |
| K002154 | EMD ELECTRONIC MEDICAL DEVICES, CORP. | K.E.A.T. | 03/22/2001 |
| K971527 | EMPI | INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM | 06/30/1997 |
| K964577 | EMPI | INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205) | 01/24/1997 |
| K972054 | EMPI | INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE | 08/14/1997 |
| K954272 | EMPI | INNOVA RECTAL STIMULATON ELECTRODE | 04/15/1996 |
| K970307 | EMPI | MINNOVA PELVIC FLOOR STIMULATION SYSTEM | 04/22/1997 |
| K983206 | EMPI | SMALL VAGINAL/RECTAL ELECTRODE | 11/03/1998 |
| K161349 | EVERYWAY MEDICAL INSTRUMENT CO., LTD. | Everyway Incontinence Stimulation System | 07/07/2017 |
| K213116 | Everyway Medical Instruments Co., Ltd. | Everyway Incontinence Stimulation System | 12/03/2021 |
| K122194 | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE | 04/04/2013 |
| K234061 | Fotona d.o.o. | StarFormer | 07/01/2024 |
| K161055 | Fuji Dynamics Ltd | Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji û 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 | 07/12/2016 |
| K140265 | GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD | ELECTRODE FOR URINARY INCONTINENCE | 01/23/2015 |
| K142369 | GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD | Urinary Incontinence System | 06/17/2015 |
| K011435 | HMT, INC. | HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM | 06/22/2001 |
| K990456 | HOLLISTER, INC. | ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP | 03/25/1999 |
| K050483 | HOLLISTER, INC. | EVADRI BLADDER CONTROL SYSTEMS | 04/12/2005 |
| K961872 | HOLLISTER, INC. | INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER | 08/09/1996 |
| K974048 | HOLLISTER, INC. | INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER | 12/23/1997 |
| K013141 | HOLLISTER, INC. | MICROGYN PLUS STIMULATION DEVICE | 12/19/2001 |
| K963222 | HOLLISTER, INC. | MICROGYN PLUS STIMULATION DEVICE | 10/23/1996 |
| K971541 | HOLLISTER, INC. | VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON | 06/25/1997 |
| K970602 | HOLLISTER, INC. | VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL | 04/15/1997 |
| K141158 | INCONTROL MEDICAL, LLC | APEX | 11/26/2014 |
| K150183 | InControl Medical, LLC | ApexM | 04/09/2015 |
| K182022 | InControl Medical, LLC | ApexMV | 03/15/2019 |
| K110179 | INCONTROL MEDICAL, LLC | INCONTROL | 02/22/2012 |
| K133826 | INCONTROL MEDICAL, LLC | INTONEMV | 01/06/2014 |
| K134020 | INCONTROL MEDICAL, LLC | INTONEMV | 02/25/2014 |
| K150180 | INCONTROL MEDICAL, LLC. | InTone | 03/16/2015 |
| K200293 | InMode Ltd. | InMode System with vTone Applicator | 05/05/2020 |
| K994109 | INNOVAMED USA, INC. | DETRUSAN 500 | 08/03/2000 |
| K141643 | INTERNATIONAL TRADE GROUP, INC. | YARLAP | 04/24/2015 |
| K160773 | INTERNATIONAL TRADE GROUP, INC. | Yarlap II | 05/04/2016 |
| K993721 | LABORIE MEDICAL TECH CORP. | UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES | 11/29/1999 |
| K990041 | LABORIE MEDICAL TECH CORP. | UROSTYM BIOFEEDBACK AND STIMULATION PROBES | 08/05/1999 |
| K070331 | LABORIE MEDICAL TECHNOLOGIES | UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES | 05/04/2007 |
| K962009 | LABORIE MEDICAL TECHNOLOGIES, LTD. | UROSTYM | 05/20/1997 |
| K230767 | Nanjing Vishee Medical Technology Co., Ltd. | Pelvic Floor Muscle Stimulator | 09/21/2023 |
| K081480 | NE SERVICES LTD. | KEGEL8 PELVIC EXERCISER, MODEL OPH 400 | 09/12/2008 |
| K001903 | NEOTONUS, INC. | NEOCONTROL PELVIC FLOOR THERAPY SYSTEM | 08/29/2000 |
| K973096 | NEOTONUS, INC. | NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM | 06/12/1998 |
| K213133 | Oriental Inspiration Limited | Keffort (MC-100, MC-100A) | 04/13/2022 |
| K171430 | Shenzhen Dongdixin Technology Co., Ltd | Incontinence Treatment Device, Model LT2061 | 03/15/2018 |
| K233576 | Shenzhen Konmed Technology Co., Ltd. | Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) | 02/23/2024 |
| K163288 | Shenzhen Konmed Technology Co., Ltd. | Pelvifine Pelvic Muscle Trainer | 01/18/2018 |
| K220161 | Shenzhen Konmed Technology Co.,Ltd. | Biofeedback Nerve and Muscle Stimulator | 07/20/2022 |
| K210441 | Shenzhen Med-link Electronics Tech Co, Ltd | Incontinence Probe | 09/17/2021 |
| K053007 | SKYLARK DEVICE & SYSTEMS CO., LTD | SKYLARK URO PROBE | 12/05/2005 |
| K230983 | TensCare Ltd | Unicare (K-UNICARE-USA) | 10/20/2023 |
| K191312 | TensCare Ltd. | Perfect PFE | 11/01/2019 |
| K103698 | TENSCARE LTD. | TENSCARE ITOUCH SURE MODEL ITS | 06/21/2011 |
| K142506 | TENSCARE LTD. | TensCare KegelFit | 04/20/2015 |
| K001515 | THE PROMETHEUS GROUP | PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000 | 07/31/2000 |
| K023906 | THE PROMETHEUS GROUP | PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM | 02/19/2003 |
| K030039 | THE PROMETHEUS GROUP | PATHWAY STM-10 PELVIC FLOOR STIMULATOR | 05/23/2003 |
| K993976 | THE PROMETHEUS GROUP | PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR | 02/22/2000 |
| K201014 | Thought Technology LTD. | MyOnyx System | 01/13/2021 |
| K053434 | THOUGHT TECHNOLOGY LTD. | MYOTRAC INFINITI ELECTRICAL STIMULATOR | 03/15/2006 |
| K960496 | UTAH MEDICAL PRODUCTS, INC. | LIBERTY LITE PFS SYSTEM | 06/27/1996 |
| K970077 | UTAH MEDICAL PRODUCTS, INC. | LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) | 05/23/1997 |
| K964526 | UTAH MEDICAL PRODUCTS, INC. | LIBERTY RECTAL PELVIC FLOOR EXERCISER | 02/10/1997 |
| K083704 | VERITY SCIENTIFIC LTD. | NUTRAC PELVATOR, MODEL PEL 200 | 07/14/2009 |
| K222528 | Well-Life Healthcare Limited | Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode | 12/29/2022 |
| K230780 | Zimmer MedizinSysteme GmbH | MFG-05 | 10/05/2023 |
| K241862 | ZMI Electronics Ltd. | Levina Pelvic Floor Muscle Stimulator (RS-48) | 03/27/2025 |
| K231166 | ZMI Electronics Ltd. | Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes | 01/18/2024 |
| K121820 | ZYNEX MEDICAL, INC. | INWAVE | 08/24/2012 |
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