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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, nerve, transcutaneous, over-the-counter
510(k) Number K163166
Device Name EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only
Applicant
EASYWELL BIOMEDICALS, INC.
SUITE 2, 2F, NO.9, JHANYE 1 RD. HSINCHU SCIENCE PARK
Hsinchu,  TW
Applicant Contact ARTHUR CHEN
Correspondent
EASYWELL BIOMEDICALS, INC.
SUITE 2, 2F, NO.9, JHANYE 1 RD. HSINCHU SCIENCE PARK
Hsinchu,  TW
Correspondent Contact ARTHUR CHEN
Regulation Number882.5890
Classification Product Code
NUH  
Date Received11/14/2016
Decision Date 08/11/2017
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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