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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered, for muscle conditioning
510(k) Number K162744
Device Name Everyway OTC EMS, Model EV-805
Applicant
EVERYWAY MEDICAL INSTRUMENT CO., LTD.
3FL., NO. 5, LANE 155, SECTION 3,
PEISHEN RD.
SHENKENG DIST, NEW TAIPEI CITY,  TW 222
Applicant Contact PAUL HUNG
Correspondent
EVERYWAY MEDICAL INSTRUMENT CO., LTD.
3FL., NO. 5, LANE 155, SECTION 3,
PEISHEN RD.
SHENKENG DIST, NEW TAIPEI CITY,  TW 222
Correspondent Contact PAUL HUNG
Regulation Number890.5850
Classification Product Code
NGX  
Date Received09/30/2016
Decision Date 08/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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