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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
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