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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 K171026
Device Name Mytens Model: BW-TSX
Applicant
Bewell Connect Corp.
Suite 410, 185 Alewife Brook Pkwy.
Cambridge,  MA  02138
Applicant Contact Jacob Chen
Correspondent
Bewell Connect Corp.
Suite 410, 185 Alewife Brook Pkwy.
Cambridge,  MA  02138
Correspondent Contact Jacob Chen
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received04/05/2017
Decision Date 11/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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