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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 K172919
Device Name EV-804 OTC Pain Relief TENS
Applicant
Everyway Medical Instruments Co., Ltd.
3Fl., No. 5, Lane 155, Sec. 3, Peishen Rd.
Shenkeng Dist
New Taipei City,  TW 22203
Applicant Contact Paul Hung
Correspondent
Everyway Medical Instruments Co., Ltd.
3Fl., No. 5, Lane 155, Sec. 3, Peishen Rd.
Shenkeng Dist
New Taipei City,  TW 22203
Correspondent Contact Paul Hung
Regulation Number882.5890
Classification Product Code
NUH  
Date Received09/25/2017
Decision Date 04/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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