KPI · Stimulator, Electrical, Non-Implantable, For Incontinence

Device class

Class II

Regulation 876.5320

Total clearances

2020-05-05 → 2026-06-18

Last 12 months

Unique sponsors

Classification details

Medical specialty

Gastroenterology, Urology

Review panel

Regulation number

876.5320

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Shenzhen Konmed Technology Co., Ltd.	3	1	2026-06-18
Zmi Electronics , Ltd.	2	0	2025-03-27
Well-Life Healthcare , Ltd.	2	1	2026-02-12
Shenzhen Changkun Technology Co., Ltd.	1	1	2026-05-06
Oriental Inspiration Limited	1	0	2022-04-13
Fotona D.O.O.	1	0	2024-07-01
Pontemedag	1	1	2026-04-17
Dolanvy (Suzhou) Medical Technology Co., Ltd.	1	1	2026-04-28
Verity Medical , Ltd.	1	0	2025-06-26
Hunan Accurate Bio-Medical Technology Co., Ltd.	1	1	2026-05-14
InMode , Ltd.	1	0	2020-05-05
Trinity Medical Solutions	1	1	2025-08-29
Thought Technology , Ltd.	1	0	2021-01-13
Easymed Instruments Co., Ltd.	1	0	2024-11-27
Shenzhen Med-Link Electronics Tech Co., Ltd.	1	0	2021-09-17
BTL Industries, Inc.	1	0	2025-02-10
Nanjing Vishee Medical Technology Co., Ltd.	1	0	2023-09-21
Tenscare, Ltd.	1	0	2023-10-20
Everyway Medical Instruments Co.,Ltd	1	0	2021-12-03
Zimmer Medizinsysteme GmbH	1	0	2023-10-05

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
E0740	HCPCS	Non-implanted pelvic floor electrical stimulator, complete system ✓ CMS-verified description	High	Neuromuscular stimulator; electric; non-implantable
E0745	HCPCS	Neuromuscular stimulator, electronic shock unit ✓ CMS-verified description	High	Neuromuscular stimulator; electric; non-implantable; portable, programmable
53400	CPT	—	Medium	Urinary incontinence procedure; abdominal approach

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-18	K260178	Shenzhen Konmed Technology Co., Ltd.	Pelvic Muscle Trainer (KM510, KM516B)
2026-05-14	K252601	Hunan Accurate Bio-Medical Technology Co., Ltd.	Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)
2026-05-06	K252552	Shenzhen Changkun Technology Co., Ltd.	Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
2026-04-28	K252831	Dolanvy (Suzhou) Medical Technology Co., Ltd.	Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
2026-04-17	K252334	Pontemedag	PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)
2026-02-12	K251760	Well-Life Healthcare , Ltd.	Well-Life Incontinence Stimulation System (WL-2405i(P))
2025-08-29	K251026	Trinity Medical Solutions	Regenesis EMS Chair
2025-06-26	K243079	Verity Medical , Ltd.	NeuroTrac® MyoPlus Pro (MYO120U)
2025-03-27	K241862	Zmi Electronics , Ltd.	Levina Pelvic Floor Muscle Stimulator (RS-48)
2025-02-10	K241516	BTL Industries, Inc.	BTL-398
2024-11-27	K241899	Easymed Instruments Co., Ltd.	Pelvic Floor Stimulator (Intrelief PFE)
2024-07-01	K234061	Fotona D.O.O.	StarFormer
2024-02-23	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)
2024-01-18	K231166	Zmi Electronics , Ltd.	Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes
2023-10-20	K230983	Tenscare, Ltd.	Unicare (K-UNICARE-USA)
2023-10-05	K230780	Zimmer Medizinsysteme GmbH	MFG-05
2023-09-21	K230767	Nanjing Vishee Medical Technology Co., Ltd.	Pelvic Floor Muscle Stimulator
2022-12-29	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
2022-07-20	K220161	Shenzhen Konmed Technology Co., Ltd.	Biofeedback Nerve and Muscle Stimulator
2022-04-13	K213133	Oriental Inspiration Limited	Keffort (MC-100, MC-100A)
2021-12-03	K213116	Everyway Medical Instruments Co.,Ltd	Everyway Incontinence Stimulation System
2021-09-17	K210441	Shenzhen Med-Link Electronics Tech Co., Ltd.	Incontinence Probe
2021-01-13	K201014	Thought Technology , Ltd.	MyOnyx System
2020-05-05	K200293	InMode , Ltd.	InMode System with vTone Applicator