Well-Life Incontinence Stimulation System (WL-2405i(P))
FDA 510(k) K251760 · Well-Life Healthcare , Ltd.
510(k) numberK251760
Submission
- Device name
- Well-Life Incontinence Stimulation System (WL-2405i(P))
- Applicant
- Well-Life Healthcare , Ltd.
New Taipei City, TW - Received
- June 9, 2025
- Decision date
- February 12, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KPI – Stimulator, Electrical, Non-Implantable, For Incontinence
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5320
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KPI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260178 | Pelvic Muscle Trainer (KM510, KM516B)KPI · Traditional | Shenzhen Konmed Technology Co., Ltd. | 06/18/2026SE |
| K252601 | Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer…KPI · Traditional | Hunan Accurate Bio-Medical Technology Co., Ltd. | 05/14/2026SE |
| K252552 | Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)KPI · Traditional | Shenzhen Changkun Technology Co., Ltd. | 05/06/2026SE |
| K252831 | Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924…KPI · Traditional | Dolanvy (Suzhou) Medical Technology Co., Ltd. | 04/28/2026SE |
| K252334 | PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)KPI · Traditional | Pontemedag | 04/17/2026SE |
| K251026 | Regenesis EMS ChairKPI · Traditional | Trinity Medical Solutions | 08/29/2025SE |
| K243079 | NeuroTrac® MyoPlus Pro (MYO120U)KPI · Traditional | Verity Medical , Ltd. | 06/26/2025SE |
| K241862 | Levina Pelvic Floor Muscle Stimulator (RS-48)KPI · Traditional | Zmi Electronics , Ltd. | 03/27/2025SE |
| K241516 | BTL-398KPI · Traditional | BTL Industries, Inc. | 02/10/2025SE |
| K241899 | Pelvic Floor Stimulator (Intrelief PFE)KPI · Traditional | Easymed Instruments Co., Ltd. | 11/27/2024SE |
More from Easymed Instruments Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K233054 | Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual…NUH · Traditional | 10/18/2024SE |
| K222528 | Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence…KPI · Traditional | 12/29/2022SE |
| K220524 | Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)NUH · Traditional | 08/04/2022SE |
| K213091 | Well-Life TENS/EMS/Heating StimulatorNUH · Traditional | 02/19/2022SE |
| K200942 | Well-Life Garment Electrodes (GM Series)GXY · Traditional | 06/01/2021SE |
| K172809 | OTC Combo TENS/EMS SystemNUH · Special | 10/18/2017SE |
| K162663 | WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and…GZJ · Traditional | 01/17/2017SE |
| K161453 | WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605ANUH · Traditional | 12/05/2016SE |
| K141299 | OTC Combo Tens/Ems SystemNUH · Traditional | 11/14/2014SE |
| K133723 | OTC PatchNUH · Abbreviated | 01/28/2014SE |
Questions and answers
When was Well-Life Incontinence Stimulation System (WL-2405i(P)) cleared by the FDA?
Well-Life Incontinence Stimulation System (WL-2405i(P)) (K251760) received a 510(k) decision of Substantially Equivalent on February 12, 2026, 248 days after the submission was received.
What is the product code of K251760?
The FDA product code is KPI – Stimulator, Electrical, Non-Implantable, For Incontinence, a Class II (moderate risk) device regulated under 21 CFR 876.5320.