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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 K181849
Device Name iStim S2 OTC Pain Relief TENS
Everyway Medical Instruments CO., LDT.
3 Fl., No. 5, Lane 155, Sec.3 Beishen Rd.
Shenkeng Dist.
New Taipei City,  TW 22203
Applicant Contact Paul Hung
DuVal & Associates
825 Nicollet Mall, Suite 1820
Minneapolis,  MN  55402
Correspondent Contact Aaron Hage
Regulation Number882.5890
Classification Product Code
Date Received07/11/2018
Decision Date 08/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No