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FDA 510(k)

Well-Life Incontinence Stimulation System (WL-2405i(P))

K-Number: K251760 · 2026-02-12

ApplicantWell-Life Healthcare , Ltd.
Decision Date2026-02-12
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Well-Life Incontinence Stimulation System (WL-2405i(P)) is the device name listed in this FDA 510(k) record. The listed applicant is Well-Life Healthcare , Ltd.. It received FDA 510(k) clearance on 2026-02-12 under 510(k) number K251760. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Well-Life Incontinence Stimulation System (WL-2405i(P))?

Well-Life Incontinence Stimulation System (WL-2405i(P)) is a medical device that received FDA 510(k) clearance on 2026-02-12. The listed applicant is Well-Life Healthcare , Ltd.. The 510(k) number is K251760.

When did Well-Life Incontinence Stimulation System (WL-2405i(P)) receive FDA 510(k) clearance?

Well-Life Incontinence Stimulation System (WL-2405i(P)) received FDA 510(k) clearance on 2026-02-12, under 510(k) number K251760.

Who is the listed applicant for Well-Life Incontinence Stimulation System (WL-2405i(P))?

The FDA 510(k) record lists Well-Life Healthcare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Well-Life Incontinence Stimulation System (WL-2405i(P))?

The FDA product code for Well-Life Incontinence Stimulation System (WL-2405i(P)) is KPI.

Other records listing Well-Life Healthcare , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233054Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus StimulatorK222528Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe ElectrodeK220524Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)K213091Well-Life TENS/EMS/Heating StimulatorK200942Well-Life Garment Electrodes (GM Series)K172809OTC Combo TENS/EMS System

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Related Devices (Code: KPI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)Hunan Accurate Bio-Medical Technology Co., Ltd.K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.K252831Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)Dolanvy (Suzhou) Medical Technology Co., Ltd.K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)PontemedagK251026Regenesis EMS ChairTrinity Medical Solutions

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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