Product Code: KPI FDA class 2 21 CFR 876.5320

Stimulator, Electrical, Non-Implantable, For Incontinence

Gastroenterology, Urology

This device is a non-implantable electrical stimulator used to treat urinary or fecal incontinence by delivering controlled electrical impulses to pelvic floor muscles or nerves to restore continence. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPI, regulated under 21 CFR 876.5320 within the Gastroenterology and Urology specialty. This device is eligible for third-party review.

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Basic Information

Product Code: KPI
Device Class: FDA class 2
Regulation Number: 876.5320
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 96 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260178	Pelvic Muscle Trainer (KM510, KM516B)	Jun 18, 2026	Substantially Equivalent	Shenzhen Konmed Technology Co., Ltd.
K252601	Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)	May 14, 2026	Substantially Equivalent	Hunan Accurate Bio-Medical Technology Co., Ltd.
K252552	Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)	May 06, 2026	Substantially Equivalent	Shenzhen Changkun Technology Co., Ltd.
K252831	Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)	Apr 28, 2026	Substantially Equivalent	Dolanvy (Suzhou) Medical Technology Co., Ltd.
K252334	PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)	Apr 17, 2026	Substantially Equivalent	Pontemedag
K251760	Well-Life Incontinence Stimulation System (WL-2405i(P))	Feb 12, 2026	Substantially Equivalent	Well-Life Healthcare , Ltd.
K251026	Regenesis EMS Chair	Aug 29, 2025	Substantially Equivalent	Trinity Medical Solutions
K243079	NeuroTrac® MyoPlus Pro (MYO120U)	Jun 26, 2025	Substantially Equivalent	Verity Medical , Ltd.
K241862	Levina Pelvic Floor Muscle Stimulator (RS-48)	Mar 27, 2025	Substantially Equivalent	Zmi Electronics , Ltd.
K241516	BTL-398	Feb 10, 2025	Substantially Equivalent	BTL Industries, Inc.
K241899	Pelvic Floor Stimulator (Intrelief PFE)	Nov 27, 2024	Substantially Equivalent	Easymed Instruments Co., Ltd.
K234061	StarFormer	Jul 01, 2024	Substantially Equivalent	Fotona D.O.O.
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)	Feb 23, 2024	Substantially Equivalent	Shenzhen Konmed Technology Co., Ltd.
K231166	Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes	Jan 18, 2024	Substantially Equivalent	Zmi Electronics , Ltd.
K230983	Unicare (K-UNICARE-USA)	Oct 20, 2023	Substantially Equivalent	Tenscare, Ltd.
K230780	MFG-05	Oct 05, 2023	Substantially Equivalent	Zimmer Medizinsysteme GmbH
K230767	Pelvic Floor Muscle Stimulator	Sep 21, 2023	Substantially Equivalent	Nanjing Vishee Medical Technology Co., Ltd.
K222528	Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode	Dec 29, 2022	Substantially Equivalent	Well-Life Healthcare Limited
K220161	Biofeedback Nerve and Muscle Stimulator	Jul 20, 2022	Substantially Equivalent	Shenzhen Konmed Technology Co., Ltd.
K213133	Keffort (MC-100, MC-100A)	Apr 13, 2022	Substantially Equivalent	Oriental Inspiration Limited
K213116	Everyway Incontinence Stimulation System	Dec 03, 2021	Substantially Equivalent	Everyway Medical Instruments Co.,Ltd
K210441	Incontinence Probe	Sep 17, 2021	Substantially Equivalent	Shenzhen Med-Link Electronics Tech Co., Ltd.
K201014	MyOnyx System	Jan 13, 2021	Substantially Equivalent	Thought Technology , Ltd.
K200293	InMode System with vTone Applicator	May 05, 2020	Substantially Equivalent	InMode , Ltd.
K191312	Perfect PFE	Nov 01, 2019	Substantially Equivalent	Tenscare, Ltd.
K182022	ApexMV	Mar 15, 2019	Unknown	Incontrol Medical, LLC
K181497	HPM-6000UF	Nov 14, 2018	Substantially Equivalent	BTL Industries, Inc.
K171430	Incontinence Treatment Device, Model LT2061	Mar 15, 2018	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.
K163288	Pelvifine Pelvic Muscle Trainer	Jan 18, 2018	Substantially Equivalent	Shenzhen Konmed Technology Co., Ltd.
K161349	Everyway Incontinence Stimulation System	Jul 07, 2017	Substantially Equivalent	Everyway Medical Instrument Co., Ltd.
K162010	HPM-6000U	Dec 13, 2016	Substantially Equivalent	BTL Industries, Inc.
K161055	Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15	Jul 12, 2016	Substantially Equivalent	Fuji Dynamics , Ltd.
K160773	Yarlap II	May 04, 2016	Substantially Equivalent	International Trade Group, Inc.
K142369	Urinary Incontinence System	Jun 17, 2015	Substantially Equivalent	Guangzhou Finecure Medical Equipment Co.,Ltd
K141643	YARLAP	Apr 24, 2015	Substantially Equivalent	International Trade Group, Inc.
K142506	TensCare KegelFit	Apr 20, 2015	Substantially Equivalent	Tenscare, Ltd.
K150183	ApexM	Apr 09, 2015	Substantially Equivalent	Incontrol Medical, LLC
K150180	InTone	Mar 16, 2015	Substantially Equivalent	Incontrol Medical, LLC
K140265	ELECTRODE FOR URINARY INCONTINENCE	Jan 23, 2015	Substantially Equivalent	Guangzhou Finecure Medical Equipment Co.,Ltd
K141158	APEX	Nov 26, 2014	Substantially Equivalent	Incontrol Medical, LLC
K134020	INTONEMV	Feb 25, 2014	Substantially Equivalent	Incontrol Medical, LLC
K133826	INTONEMV	Jan 06, 2014	Substantially Equivalent	Incontrol Medical, LLC
K122194	LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE	Apr 04, 2013	Substantially Equivalent	Everyway Medical Instruments Co.,Ltd
K121820	INWAVE	Aug 24, 2012	Substantially Equivalent	Zynex Medical, Inc.
K110179	INCONTROL	Feb 22, 2012	Substantially Equivalent	Incontrol Medical, LLC
K103698	TENSCARE ITOUCH SURE MODEL ITS	Jun 21, 2011	Substantially Equivalent	Tenscare, Ltd.
K093600	OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM	Dec 04, 2009	Substantially Equivalent	Accelerated Care Plus
K083704	NUTRAC PELVATOR, MODEL PEL 200	Jul 14, 2009	Substantially Equivalent	Verity Scientific , Ltd.
K081480	KEGEL8 PELVIC EXERCISER, MODEL OPH 400	Sep 12, 2008	Substantially Equivalent	Ne Services , Ltd.
K070331	UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES	May 04, 2007	Substantially Equivalent	Laborie Medical Technologies
K053434	MYOTRAC INFINITI ELECTRICAL STIMULATOR	Mar 15, 2006	Substantially Equivalent	Thought Technology , Ltd.
K053007	SKYLARK URO PROBE	Dec 05, 2005	Substantially Equivalent	Skylark Device & Systems Co., Ltd.
K050483	EVADRI BLADDER CONTROL SYSTEMS	Apr 12, 2005	Substantially Equivalent	Hollister, Inc.
K033256	ATHENA PELVIC MUSCLE TRAINER II	Dec 30, 2003	Substantially Equivalent	Athena Feminine Technologies, Inc.
K032988	ELPHA 4 CONTI	Dec 03, 2003	Substantially Equivalent	Danmeter A/S
K030039	PATHWAY STM-10 PELVIC FLOOR STIMULATOR	May 23, 2003	Substantially Equivalent	The Prometheus Group
K023905	ATHENA PELVIC MUSCLE TRAINER	Apr 30, 2003	Substantially Equivalent	Athena Feminine Technologies, Inc.
K023906	PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM	Feb 19, 2003	Substantially Equivalent	The Prometheus Group
K013141	MICROGYN PLUS STIMULATION DEVICE	Dec 19, 2001	Substantially Equivalent	Hollister, Inc.
K011435	HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM	Jun 22, 2001	Substantially Equivalent	Hmt, Inc.
K002154	K.E.A.T.	Mar 22, 2001	Substantially Equivalent	Emd Electronic Medical Devices, Corp.
K001903	NEOCONTROL PELVIC FLOOR THERAPY SYSTEM	Aug 29, 2000	Substantially Equivalent	Neotonus, Inc.
K994109	DETRUSAN 500	Aug 03, 2000	Substantially Equivalent	Innovamed USA, Inc.
K001515	PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000	Jul 31, 2000	Substantially Equivalent	The Prometheus Group
K993976	PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR	Feb 22, 2000	Substantially Equivalent	The Prometheus Group
K993721	UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES	Nov 29, 1999	Substantially Equivalent	Laborie Medical Tech Corp.
K990041	UROSTYM BIOFEEDBACK AND STIMULATION PROBES	Aug 05, 1999	Substantially Equivalent	Laborie Medical Tech Corp.
K990456	ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP	Mar 25, 1999	Substantially Equivalent	Hollister, Inc.
K983206	SMALL VAGINAL/RECTAL ELECTRODE	Nov 03, 1998	Substantially Equivalent	Empi
K973096	NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM	Jun 12, 1998	Substantially Equivalent	Neotonus, Inc.
K974048	INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER	Dec 23, 1997	Substantially Equivalent	Hollister, Inc.
K972054	INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE	Aug 14, 1997	Substantially Equivalent	Empi
K964738	ELPHA 2000 CONTI	Aug 14, 1997	Substantially Equivalent	Dan Med, Inc.
K971527	INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM	Jun 30, 1997	Substantially Equivalent	Empi
K971541	VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON	Jun 25, 1997	Substantially Equivalent	Hollister, Inc.
K970077	LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044)	May 23, 1997	Substantially Equivalent	Utah Medical Products, Inc.
K962009	UROSTYM	May 20, 1997	Substantially Equivalent	Laborie Medical Technologies, Ltd.
K970307	MINNOVA PELVIC FLOOR STIMULATION SYSTEM	Apr 22, 1997	Substantially Equivalent	Empi
K970602	VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL	Apr 15, 1997	Substantially Equivalent	Hollister, Inc.
K964526	LIBERTY RECTAL PELVIC FLOOR EXERCISER	Feb 10, 1997	Substantially Equivalent	Utah Medical Products, Inc.
K964577	INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205)	Jan 24, 1997	Substantially Equivalent	Empi
K963222	MICROGYN PLUS STIMULATION DEVICE	Oct 23, 1996	Substantially Equivalent	Hollister, Inc.
K961872	INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER	Aug 09, 1996	Substantially Equivalent	Hollister, Inc.
K960496	LIBERTY LITE PFS SYSTEM	Jun 27, 1996	Substantially Equivalent	Utah Medical Products, Inc.
K954272	INNOVA RECTAL STIMULATON ELECTRODE	Apr 15, 1996	Substantially Equivalent	Empi
K930530	INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC	Oct 17, 1995	Substantially Equivalent	Hollister, Inc.
K945292	TS-700P CONTROL XP ELECTRICAL STIMULATOR	Apr 12, 1995	Substantially Equivalent	Myo/Kinetic Systems, Inc.
K943250	LIBERTY	Feb 09, 1995	Substantially Equivalent	Utah Medical Products, Inc.
K941911	INNOVA PELVIC FLOOR STIMULATION SYSTEM	Jan 20, 1995	Substantially Equivalent	Empi
K922562	STIMTECH PFX, CATALOG NUMBER 78-8540	Oct 13, 1993	Substantially Equivalent	Stimtech Products
K910081	TBD	Jul 15, 1991	Substantially Equivalent	Empi
K891007	NONIMPLANTED ELECTRICAL CONTINENCE DEVICE	Jun 07, 1990	Substantially Equivalent	Tridak Division of Indicon, Inc.
K891773	MICROGYN II ELEC STIM DEVICE TREAT OF URIN INCONTI	Aug 23, 1989	Substantially Equivalent	Hollister, Inc.
K874867	CATR(TM)-H CARDIOTOMY HOLDER	Feb 02, 1988	Substantially Equivalent	Bentley Laboratories, Inc.
K850167	}IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR	Apr 09, 1985	Substantially Equivalent	Urologics, Inc.
K761145	RADIOISOTOPE CALIBRATOR (CRCO-22NB)	Dec 16, 1976	Substantially Equivalent	G.D. Searle and Co.