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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 K151479
Device Name EV-820 OTC Pain Relief TENS
Applicant
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
3 FL., NO. 5, Lane 155, Section 3, Peishen Rd.,
Shenkeng Hsiang, Taipei Hsien,  TW 222
Applicant Contact Robert Tu
Correspondent
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
3 FL., NO. 5, Lane 155, Section 3, Peishen Rd.,
Shenkeng Hsiang, Taipei Hsien,  TW 222
Correspondent Contact Robert Tu
Regulation Number882.5890
Classification Product Code
NUH  
Date Received06/02/2015
Decision Date 10/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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