FDA Product Code
FDA Product Code KPI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5320
510(k) Clearances — 97 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262353 | BTL-299-F | BTL Industries, Inc. | 2026-09-23 | Traditional | PDF ↗ |
| K260178 | Pelvic Muscle Trainer (KM510, KM516B) | Shenzhen Konmed Technology Co., Ltd. | 2026-06-18 | Traditional | PDF ↗ |
| K252601 | Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2026-05-14 | Traditional | PDF ↗ |
| K252552 | Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) | Shenzhen Changkun Technology Co., Ltd. | 2026-05-06 | Traditional | PDF ↗ |
| 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. | 2026-04-28 | Traditional | PDF ↗ |
| K252334 | PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) | Pontemedag | 2026-04-17 | Traditional | PDF ↗ |
| K251760 | Well-Life Incontinence Stimulation System (WL-2405i(P)) | Well-Life Healthcare , Ltd. | 2026-02-12 | Traditional | PDF ↗ |
| K251026 | Regenesis EMS Chair | Trinity Medical Solutions | 2025-08-29 | Traditional | PDF ↗ |
| K243079 | NeuroTrac® MyoPlus Pro (MYO120U) | Verity Medical , Ltd. | 2025-06-26 | Traditional | PDF ↗ |
| K241862 | Levina Pelvic Floor Muscle Stimulator (RS-48) | Zmi Electronics , Ltd. | 2025-03-27 | Traditional | PDF ↗ |
| K241516 | BTL-398 | BTL Industries, Inc. | 2025-02-10 | Traditional | PDF ↗ |
| K241899 | Pelvic Floor Stimulator (Intrelief PFE) | Easymed Instruments Co., Ltd. | 2024-11-27 | Traditional | PDF ↗ |
| K234061 | StarFormer | Fotona D.O.O. | 2024-07-01 | Traditional | PDF ↗ |
| K233576 | Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) | Shenzhen Konmed Technology Co., Ltd. | 2024-02-23 | Traditional | PDF ↗ |
| K231166 | Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes | Zmi Electronics , Ltd. | 2024-01-18 | Traditional | PDF ↗ |
| K230983 | Unicare (K-UNICARE-USA) | Tenscare, Ltd. | 2023-10-20 | Traditional | PDF ↗ |
| K230780 | MFG-05 | Zimmer Medizinsysteme GmbH | 2023-10-05 | Traditional | PDF ↗ |
| K230767 | Pelvic Floor Muscle Stimulator | Nanjing Vishee Medical Technology Co., Ltd. | 2023-09-21 | Traditional | PDF ↗ |
| K222528 | Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode | Well-Life Healthcare Limited | 2022-12-29 | Traditional | PDF ↗ |
| K220161 | Biofeedback Nerve and Muscle Stimulator | Shenzhen Konmed Technology Co., Ltd. | 2022-07-20 | Traditional | PDF ↗ |
| K213133 | Keffort (MC-100, MC-100A) | Oriental Inspiration Limited | 2022-04-13 | Traditional | PDF ↗ |
| K213116 | Everyway Incontinence Stimulation System | Everyway Medical Instruments Co.,Ltd | 2021-12-03 | Traditional | PDF ↗ |
| K210441 | Incontinence Probe | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2021-09-17 | Traditional | PDF ↗ |
| K201014 | MyOnyx System | Thought Technology , Ltd. | 2021-01-13 | Traditional | PDF ↗ |
| K200293 | InMode System with vTone Applicator | InMode , Ltd. | 2020-05-05 | Traditional | PDF ↗ |
| K191312 | Perfect PFE | Tenscare, Ltd. | 2019-11-01 | Traditional | PDF ↗ |
| K182022 | ApexMV | Incontrol Medical, LLC | 2019-03-15 | Traditional | PDF ↗ |
| K181497 | HPM-6000UF | BTL Industries, Inc. | 2018-11-14 | Traditional | PDF ↗ |
| K171430 | Incontinence Treatment Device, Model LT2061 | Shenzhen Dongdixin Technology Co., Ltd. | 2018-03-15 | Traditional | PDF ↗ |
| K163288 | Pelvifine Pelvic Muscle Trainer | Shenzhen Konmed Technology Co., Ltd. | 2018-01-18 | Traditional | PDF ↗ |
| K161349 | Everyway Incontinence Stimulation System | Everyway Medical Instrument Co., Ltd. | 2017-07-07 | Traditional | PDF ↗ |
| K162010 | HPM-6000U | BTL Industries, Inc. | 2016-12-13 | Traditional | PDF ↗ |
| K161055 | Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 | Fuji Dynamics , Ltd. | 2016-07-12 | Traditional | PDF ↗ |
| K160773 | Yarlap II | International Trade Group, Inc. | 2016-05-04 | Traditional | PDF ↗ |
| K142369 | Urinary Incontinence System | Guangzhou Finecure Medical Equipment Co.,Ltd | 2015-06-17 | Traditional | PDF ↗ |
| K141643 | YARLAP | International Trade Group, Inc. | 2015-04-24 | Traditional | PDF ↗ |
| K142506 | TensCare KegelFit | Tenscare, Ltd. | 2015-04-20 | Traditional | PDF ↗ |
| K150183 | ApexM | Incontrol Medical, LLC | 2015-04-09 | Traditional | PDF ↗ |
| K150180 | InTone | Incontrol Medical, LLC | 2015-03-16 | Traditional | PDF ↗ |
| K140265 | ELECTRODE FOR URINARY INCONTINENCE | Guangzhou Finecure Medical Equipment Co.,Ltd | 2015-01-23 | Traditional | PDF ↗ |
| K141158 | APEX | Incontrol Medical, LLC | 2014-11-26 | Traditional | PDF ↗ |
| K134020 | INTONEMV | Incontrol Medical, LLC | 2014-02-25 | Traditional | PDF ↗ |
| K133826 | INTONEMV | Incontrol Medical, LLC | 2014-01-06 | Special | PDF ↗ |
| K122194 | LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE | Everyway Medical Instruments Co.,Ltd | 2013-04-04 | Traditional | PDF ↗ |
| K121820 | INWAVE | Zynex Medical, Inc. | 2012-08-24 | Abbreviated | PDF ↗ |
| K110179 | INCONTROL | Incontrol Medical, LLC | 2012-02-22 | Traditional | PDF ↗ |
| K103698 | TENSCARE ITOUCH SURE MODEL ITS | Tenscare, Ltd. | 2011-06-21 | Traditional | PDF ↗ |
| K093600 | OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM | Accelerated Care Plus | 2009-12-04 | Traditional | PDF ↗ |
| K083704 | NUTRAC PELVATOR, MODEL PEL 200 | Verity Scientific , Ltd. | 2009-07-14 | Traditional | PDF ↗ |
| K081480 | KEGEL8 PELVIC EXERCISER, MODEL OPH 400 | Ne Services , Ltd. | 2008-09-12 | Traditional | PDF ↗ |
| K070331 | UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES | Laborie Medical Technologies | 2007-05-04 | Traditional | PDF ↗ |
| K053434 | MYOTRAC INFINITI ELECTRICAL STIMULATOR | Thought Technology , Ltd. | 2006-03-15 | Traditional | PDF ↗ |
| K053007 | SKYLARK URO PROBE | Skylark Device & Systems Co., Ltd. | 2005-12-05 | Traditional | PDF ↗ |
| K050483 | EVADRI BLADDER CONTROL SYSTEMS | Hollister, Inc. | 2005-04-12 | Traditional | PDF ↗ |
| K033256 | ATHENA PELVIC MUSCLE TRAINER II | Athena Feminine Technologies, Inc. | 2003-12-30 | Abbreviated | PDF ↗ |
| K032988 | ELPHA 4 CONTI | Danmeter A/S | 2003-12-03 | Abbreviated | PDF ↗ |
| K030039 | PATHWAY STM-10 PELVIC FLOOR STIMULATOR | The Prometheus Group | 2003-05-23 | Traditional | PDF ↗ |
| K023905 | ATHENA PELVIC MUSCLE TRAINER | Athena Feminine Technologies, Inc. | 2003-04-30 | Traditional | PDF ↗ |
| K023906 | PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM | The Prometheus Group | 2003-02-19 | Traditional | PDF ↗ |
| K013141 | MICROGYN PLUS STIMULATION DEVICE | Hollister, Inc. | 2001-12-19 | Traditional | PDF ↗ |
| K011435 | HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM | Hmt, Inc. | 2001-06-22 | Traditional | PDF ↗ |
| K002154 | K.E.A.T. | Emd Electronic Medical Devices, Corp. | 2001-03-22 | Traditional | PDF ↗ |
| K001903 | NEOCONTROL PELVIC FLOOR THERAPY SYSTEM | Neotonus, Inc. | 2000-08-29 | Traditional | PDF ↗ |
| K994109 | DETRUSAN 500 | Innovamed USA, Inc. | 2000-08-03 | Traditional | PDF ↗ |
| K001515 | PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000 | The Prometheus Group | 2000-07-31 | Traditional | PDF ↗ |
| K993976 | PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR | The Prometheus Group | 2000-02-22 | Traditional | PDF ↗ |
| K993721 | UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES | Laborie Medical Tech Corp. | 1999-11-29 | Abbreviated | PDF ↗ |
| K990041 | UROSTYM BIOFEEDBACK AND STIMULATION PROBES | Laborie Medical Tech Corp. | 1999-08-05 | Traditional | PDF ↗ |
| K990456 | ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP | Hollister, Inc. | 1999-03-25 | Traditional | PDF ↗ |
| K983206 | SMALL VAGINAL/RECTAL ELECTRODE | Empi | 1998-11-03 | Traditional | PDF ↗ |
| K973096 | NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM | Neotonus, Inc. | 1998-06-12 | Traditional | PDF ↗ |
| K974048 | INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER | Hollister, Inc. | 1997-12-23 | Traditional | PDF ↗ |
| K964738 | ELPHA 2000 CONTI | Dan Med, Inc. | 1997-08-14 | Traditional | PDF ↗ |
| K972054 | INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE | Empi | 1997-08-14 | Traditional | PDF ↗ |
| K971527 | INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM | Empi | 1997-06-30 | Traditional | PDF ↗ |
| K971541 | VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON | Hollister, Inc. | 1997-06-25 | Traditional | PDF ↗ |
| K970077 | LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) | Utah Medical Products, Inc. | 1997-05-23 | Traditional | PDF ↗ |
| K962009 | UROSTYM | Laborie Medical Technologies, Ltd. | 1997-05-20 | Traditional | PDF ↗ |
| K970307 | MINNOVA PELVIC FLOOR STIMULATION SYSTEM | Empi | 1997-04-22 | Traditional | PDF ↗ |
| K970602 | VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL | Hollister, Inc. | 1997-04-15 | Traditional | PDF ↗ |
| K964526 | LIBERTY RECTAL PELVIC FLOOR EXERCISER | Utah Medical Products, Inc. | 1997-02-10 | Traditional | PDF ↗ |
| K964577 | INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205) | Empi | 1997-01-24 | Traditional | PDF ↗ |
| K963222 | MICROGYN PLUS STIMULATION DEVICE | Hollister, Inc. | 1996-10-23 | Traditional | PDF ↗ |
| K961872 | INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER | Hollister, Inc. | 1996-08-09 | Traditional | PDF ↗ |
| K960496 | LIBERTY LITE PFS SYSTEM | Utah Medical Products, Inc. | 1996-06-27 | Traditional | PDF ↗ |
| K954272 | INNOVA RECTAL STIMULATON ELECTRODE | Empi | 1996-04-15 | Traditional | PDF ↗ |
| K930530 | INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC | Hollister, Inc. | 1995-10-17 | Traditional | PDF ↗ |
| K945292 | TS-700P CONTROL XP ELECTRICAL STIMULATOR | Myo/Kinetic Systems, Inc. | 1995-04-12 | Traditional | PDF ↗ |
| K943250 | LIBERTY | Utah Medical Products, Inc. | 1995-02-09 | Traditional | PDF ↗ |
| K941911 | INNOVA PELVIC FLOOR STIMULATION SYSTEM | Empi | 1995-01-20 | Traditional | PDF ↗ |
| K922562 | STIMTECH PFX, CATALOG NUMBER 78-8540 | Stimtech Products | 1993-10-13 | Traditional | PDF ↗ |
| K910081 | TBD | Empi | 1991-07-15 | Traditional | PDF ↗ |
| K891007 | NONIMPLANTED ELECTRICAL CONTINENCE DEVICE | Tridak Division of Indicon, Inc. | 1990-06-07 | Traditional | PDF ↗ |
| K891773 | MICROGYN II ELEC STIM DEVICE TREAT OF URIN INCONTI | Hollister, Inc. | 1989-08-23 | Traditional | PDF ↗ |
| K874867 | CATR(TM)-H CARDIOTOMY HOLDER | Bentley Laboratories, Inc. | 1988-02-02 | Traditional | PDF ↗ |
| K850167 | }IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR | Urologics, Inc. | 1985-04-09 | Traditional | PDF ↗ |
| K761145 | RADIOISOTOPE CALIBRATOR (CRCO-22NB) | G.D. Searle and Co. | 1976-12-16 | Traditional | PDF ↗ |
Product code KPI · Class II · Gastroenterology, Urology. Data: openFDA.