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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 K181207
Device Name Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
Applicant
Everyway Medical Instruments Co., Ldt.
3 Floor , # 5, Ln. 155, Sec.3 Beishen Rd.
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 Received05/07/2018
Decision Date 06/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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