KPI · Stimulator, Electrical, Non-Implantable, For Incontinence
Gastroenterology, Urology · 21 CFR 876.5320 · Class 2
Overview
| Product Code | KPI |
|---|---|
| Device Name | Stimulator, Electrical, Non-Implantable, For Incontinence |
| Regulation | 21 CFR 876.5320 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 92)
Showing 20 most recent of 92 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252334 | PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) | Pontemedag | Apr 17, 2026 | SESE |
| K251760 | Well-Life Incontinence Stimulation System (WL-2405i(P)) | Well-Life Healthcare , Ltd. | Feb 12, 2026 | SESE |
| K251026 | Regenesis EMS Chair | Trinity Medical Solutions | Aug 29, 2025 | SESE |
| K243079 | NeuroTrac® MyoPlus Pro (MYO120U) | Verity Medical , Ltd. | Jun 26, 2025 | SESE |
| K241862 | Levina Pelvic Floor Muscle Stimulator (RS-48) | Zmi Electronics , Ltd. | Mar 27, 2025 | SESE |
| K241516 | BTL-398 | BTL Industries, Inc. | Feb 10, 2025 | SESE |
| K241899 | Pelvic Floor Stimulator (Intrelief PFE) | Easymed Instruments Co., Ltd. | Nov 27, 2024 | SESE |
| K234061 | StarFormer | Fotona D.O.O. | Jul 1, 2024 | SESE |
| 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. | Feb 23, 2024 | SESE |
| K231166 | Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes | Zmi Electronics , Ltd. | Jan 18, 2024 | SESE |
| K230983 | Unicare (K-UNICARE-USA) | Tenscare, Ltd. | Oct 20, 2023 | SESE |
| K230780 | MFG-05 | Zimmer Medizinsysteme GmbH | Oct 5, 2023 | SESE |
| K230767 | Pelvic Floor Muscle Stimulator | Nanjing Vishee Medical Technology Co., Ltd. | Sep 21, 2023 | SESE |
| 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 | Dec 29, 2022 | SESE |
| K220161 | Biofeedback Nerve and Muscle Stimulator | Shenzhen Konmed Technology Co., Ltd. | Jul 20, 2022 | SESE |
| K213133 | Keffort (MC-100, MC-100A) | Oriental Inspiration Limited | Apr 13, 2022 | SESE |
| K213116 | Everyway Incontinence Stimulation System | Everyway Medical Instruments Co.,Ltd | Dec 3, 2021 | SESE |
| K210441 | Incontinence Probe | Shenzhen Med-Link Electronics Tech Co., Ltd. | Sep 17, 2021 | SESE |
| K201014 | MyOnyx System | Thought Technology , Ltd. | Jan 13, 2021 | SESE |
| K200293 | InMode System with vTone Applicator | InMode , Ltd. | May 5, 2020 | SESE |
Top Applicants
- Hollister, Inc. — 10 clearances
- Empi — 8 clearances
- Incontrol Medical, LLC — 7 clearances
- Tenscare, Ltd. — 4 clearances
- The Prometheus Group — 4 clearances
