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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, transcutaneous electrical, aesthetic purposes
510(k) Number K142794
Device Name Everyway Facial MENS
Applicant
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
3FL, NO.5, LANE 155, SEC. 3
PERISHEN ROAD
SHEN KENG HSIANG, TAIPEI HSIEN,  TW 222
Applicant Contact ROBERT TU
Correspondent
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
3FL, NO.5, LANE 155, SEC. 3
PERISHEN ROAD
SHEN KENG HSIANG, TAIPEI HSIEN,  TW 222
Correspondent Contact ROBERT TU
Regulation Number882.5890
Classification Product Code
NFO  
Date Received09/29/2014
Decision Date 06/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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