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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 a medical device manufactured by Well-Life Healthcare , Ltd.. It received FDA 510(k) clearance on 2026-02-12 under approval 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. It is manufactured by Well-Life Healthcare , Ltd.. The 510(k) number is K251760.

When was Well-Life Incontinence Stimulation System (WL-2405i(P)) approved by the FDA?

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

What company makes Well-Life Incontinence Stimulation System (WL-2405i(P))?

Well-Life Incontinence Stimulation System (WL-2405i(P)) is manufactured by Well-Life Healthcare , Ltd..

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.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07604415 Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence RECRUITING NCT04246281 The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain COMPLETED NCT07534696 Evaluation of Non-Invasive Pelvic Floor Neuromuscular Stimulation for Urinary Incontinence After Prostatectomy ENROLLING_BY_INVITATION NCT07608614 Sleep and Performance RECRUITING

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026)

Related Devices (Code: KPI)

K162010HPM-6000UBTL Industries, Inc. K161055Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15Fuji Dynamics , Ltd. K160773Yarlap IIInternational Trade Group, Inc. K161349Everyway Incontinence Stimulation SystemEveryway Medical Instrument Co., Ltd. K181497HPM-6000UFBTL Industries, Inc. K171430Incontinence Treatment Device, Model LT2061Shenzhen Dongdixin Technology Co., Ltd.

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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