Everyway OTC EMS, Model EV-805— 510(k) K162744

Name: FDA 510(k) clearance K162744
Creator: U.S. Food and Drug Administration
Published: 2017-08-03

Substantially Equivalent

Everyway Medical Instrument Co., Ltd.

FDA 510(k) clearance K162744 for Everyway OTC EMS, Model EV-805, Substantially Equivalent on 2017-08-03. Applicant: Everyway Medical Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant: Everyway Medical Instrument Co., Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2016-09-30
Decision date: 2017-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenkeng Dist, New Taipei City, TW

Download summary PDF View on FDA.gov ↗

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