Everyway Incontinence Stimulation System— 510(k) K161349

Name: FDA 510(k) clearance K161349
Creator: U.S. Food and Drug Administration
Published: 2017-07-07

Substantially Equivalent

Everyway Medical Instrument Co., Ltd.

FDA 510(k) clearance K161349 for Everyway Incontinence Stimulation System, Substantially Equivalent on 2017-07-07. Applicant: Everyway Medical Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant: Everyway Medical Instrument Co., Ltd.
Product code: Code KPI
Device class: Class 2
Regulation: 21 CFR 876.5320
Advisory panel: Gastroenterology, Urology
Date received: 2016-05-16
Decision date: 2017-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenkeng District, New Taipei City, CN

Download summary PDF View on FDA.gov ↗

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