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FDA 510(k)

Everyway Incontinence Stimulation System

K-Number: K213116 · 2021-12-03

ApplicantEveryway Medical Instruments Co.,Ltd
Decision Date2021-12-03
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Everyway Incontinence Stimulation System is a medical device manufactured by Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2021-12-03 under approval number K213116. 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 2021-12-03. It is manufactured by Everyway Medical Instruments Co.,Ltd. The 510(k) number is K213116.

When was Everyway Incontinence Stimulation System approved by the FDA?

Everyway Incontinence Stimulation System received FDA 510(k) clearance on 2021-12-03, under approval number K213116.

What company makes Everyway Incontinence Stimulation System?

Everyway Incontinence Stimulation System is manufactured by Everyway Medical Instruments 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: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021)

Other Devices by Everyway Medical Instruments Co.,Ltd

K182767V2 OTC Pain Relief TENS K182753A6 OTC Pain Relief TENS K181707Everyway Wireless TENS & EMS Unit K172919EV-804 OTC Pain Relief TENS K173186S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D K192589Everyway OTC TENS/EMS Combination

View all 13 devices →

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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