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 |
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 |
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 |
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 |
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 |
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 |
K121820 |
ZYNEX MEDICAL, INC. |
INWAVE |
08/24/2012 |