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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 K182767
Device Name V2 OTC Pain Relief TENS
Applicant
Everyway Medical Instruments Co.,Ltd
3fl., # 5, Ln. 155, Sec. 3 Beishen Rd.
Shenkeng Dist.
New Taipei City,  TW 22203
Applicant Contact Paul Hung
Correspondent
DuVal & Associates, P.A.
825 Nicollet Mall, Suite 1820
Medical Arts Bldg.
Minneapolis,  MN  55402
Correspondent Contact Aaron Hage
Regulation Number882.5890
Classification Product Code
NUH  
Date Received09/28/2018
Decision Date 10/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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