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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 K192589
Device Name Everyway OTC TENS/EMS Combination
Applicant
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
3 FL., NO. 5, Lane 155, Section 3, Peishen Rd.,
Shenkeng District, New Taipei City,  TW 22203
Applicant Contact Paul Hung
Correspondent
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
3 FL., NO. 5, Lane 155, Section 3, Peishen Rd.,
Shenkeng District, New Taipei City,  TW 22203
Correspondent Contact Paul Hung
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received09/20/2019
Decision Date 12/19/2019
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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