Stimulator, Electrical, Non-Implantable, For Incontinence
FDA product code KPI · 88 cleared devices
Class 2
Gastroenterology, Urology
- Regulation
- 21 CFR 876.5320
- Review panel
- GU
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-12-16 – 2026-09-23
KPI
2026-09-23
KPI
2026-06-18
Pelvic Muscle Trainer (KM510, KM516B)
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KPI
2026-05-14
Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)
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KPI
2026-05-06
Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
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KPI
2026-04-28
Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
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KPI
2026-04-17
PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)
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KPI
2026-02-12
Well-Life Incontinence Stimulation System (WL-2405i(P))
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KPI
2025-08-29
Regenesis EMS Chair
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KPI
2025-06-26
NeuroTrac® MyoPlus Pro (MYO120U)
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KPI
2025-03-27
Levina Pelvic Floor Muscle Stimulator (RS-48)
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KPI
2025-02-10
BTL-398
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KPI
2024-11-27
Pelvic Floor Stimulator (Intrelief PFE)
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KPI
2024-07-01
StarFormer
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KPI
2024-02-23
Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)
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KPI
2024-01-18
Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes
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KPI
2023-10-20
Unicare (K-UNICARE-USA)
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KPI
2023-10-05
MFG-05
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KPI
2023-09-21
Pelvic Floor Muscle Stimulator
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KPI
2022-12-29
Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
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KPI
2022-07-20
Biofeedback Nerve and Muscle Stimulator
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KPI
2022-04-13
Keffort (MC-100, MC-100A)
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KPI
2021-12-03
Everyway Incontinence Stimulation System
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KPI
2021-09-17
Incontinence Probe
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KPI
2021-01-13
MyOnyx System
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KPI
2020-05-05
InMode System with vTone Applicator
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KPI
2019-11-01
Perfect PFE
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KPI
2019-03-15
ApexMV
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KPI
2018-11-14
HPM-6000UF
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KPI
2018-03-15
Incontinence Treatment Device, Model LT2061
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KPI
2018-01-18
Pelvifine Pelvic Muscle Trainer
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KPI
2017-07-07
Everyway Incontinence Stimulation System
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KPI
2016-12-13
HPM-6000U
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KPI
2016-07-12
Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15
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KPI
2016-05-04
Yarlap II
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KPI
2013-04-04
LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE
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KPI
2012-08-24
INWAVE
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KPI
2012-02-22
INCONTROL
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KPI
2011-06-21
TENSCARE ITOUCH SURE MODEL ITS
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KPI
2009-12-04
OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM
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KPI
2009-07-14
NUTRAC PELVATOR, MODEL PEL 200
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KPI
2008-09-12
KEGEL8 PELVIC EXERCISER, MODEL OPH 400
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KPI
2007-05-04
UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES
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KPI
2006-03-15
MYOTRAC INFINITI ELECTRICAL STIMULATOR
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KPI
2005-12-05
SKYLARK URO PROBE
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KPI
2005-04-12
EVADRI BLADDER CONTROL SYSTEMS
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KPI
2003-12-30
ATHENA PELVIC MUSCLE TRAINER II
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KPI
2003-12-03
ELPHA 4 CONTI
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KPI
2003-05-23
PATHWAY STM-10 PELVIC FLOOR STIMULATOR
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KPI
2003-04-30
ATHENA PELVIC MUSCLE TRAINER
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KPI
2003-02-19
PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM
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KPI
2001-12-19
MICROGYN PLUS STIMULATION DEVICE
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KPI
2001-06-22
HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM
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KPI
2001-03-22
K.E.A.T.
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KPI
2000-08-29
NEOCONTROL PELVIC FLOOR THERAPY SYSTEM
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KPI
2000-08-03
DETRUSAN 500
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KPI
2000-07-31
PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000
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KPI
2000-02-22
PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR
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KPI
1999-11-29
UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES
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KPI
1999-08-05
UROSTYM BIOFEEDBACK AND STIMULATION PROBES
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KPI
1999-03-25
ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP
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KPI
1998-11-03
SMALL VAGINAL/RECTAL ELECTRODE
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KPI
1998-06-12
NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM
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KPI
1997-12-23
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
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KPI
1997-08-14
INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE
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KPI
1997-08-14
ELPHA 2000 CONTI
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KPI
1997-06-30
INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM
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KPI
1997-06-25
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON
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KPI
1997-05-23
LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044)
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KPI
1997-05-20
UROSTYM
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KPI
1997-04-22
MINNOVA PELVIC FLOOR STIMULATION SYSTEM
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KPI
1997-04-15
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL
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KPI
1997-02-10
LIBERTY RECTAL PELVIC FLOOR EXERCISER
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KPI
1997-01-24
INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205)
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KPI
1996-10-23
MICROGYN PLUS STIMULATION DEVICE
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KPI
1996-08-09
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
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KPI
1996-06-27
LIBERTY LITE PFS SYSTEM
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KPI
1996-04-15
INNOVA RECTAL STIMULATON ELECTRODE
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KPI
1995-10-17
INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC
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KPI
1995-04-12
TS-700P CONTROL XP ELECTRICAL STIMULATOR
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KPI
1995-02-09
LIBERTY
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KPI
1995-01-20
INNOVA PELVIC FLOOR STIMULATION SYSTEM
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KPI
1993-10-13
STIMTECH PFX, CATALOG NUMBER 78-8540
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KPI
1991-07-15
TBD
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KPI
1990-06-07
NONIMPLANTED ELECTRICAL CONTINENCE DEVICE
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KPI
1989-08-23
MICROGYN II ELEC STIM DEVICE TREAT OF URIN INCONTI
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KPI
1988-02-02
CATR(TM)-H CARDIOTOMY HOLDER
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KPI
1985-04-09
}IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR
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KPI
1976-12-16
RADIOISOTOPE CALIBRATOR (CRCO-22NB)
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