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FDA 510(k)

Everyway Incontinence Stimulation System

K-Number: K161349 · 2017-07-07

ApplicantEveryway Medical Instrument Co., Ltd.
Decision Date2017-07-07
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Everyway Incontinence Stimulation System is a medical device manufactured by Everyway Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2017-07-07 under approval number K161349. 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 Everyway Incontinence Stimulation System?

Everyway Incontinence Stimulation System is a medical device that received FDA 510(k) clearance on 2017-07-07. It is manufactured by Everyway Medical Instrument Co., Ltd.. The 510(k) number is K161349.

When was Everyway Incontinence Stimulation System approved by the FDA?

Everyway Incontinence Stimulation System received FDA 510(k) clearance on 2017-07-07, under approval number K161349.

What company makes Everyway Incontinence Stimulation System?

Everyway Incontinence Stimulation System is manufactured by Everyway Medical Instrument Co., Ltd..

What is the FDA product code for Everyway Incontinence Stimulation System?

The FDA product code for Everyway Incontinence Stimulation System 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)

Other Devices by Everyway Medical Instrument Co., Ltd.

K162744Everyway OTC EMS, Model EV-805

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. K181497HPM-6000UFBTL Industries, Inc. K171430Incontinence Treatment Device, Model LT2061Shenzhen Dongdixin Technology Co., Ltd. K163288Pelvifine Pelvic Muscle TrainerShenzhen Konmed 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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