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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
510(k) Number K152432
Device Name ActiPatch(R)
Applicant
Bioelectronics Corporation
4539 Metropolitan Court
Frederick,  MD  21704
Applicant Contact ANDREW WHELAN
Correspondent
Bioelectronics Corporation
4539 Metropolitan Court
Frederick,  MD  21704
Correspondent Contact ANDREW WHELAN
Regulation Number890.5290
Classification Product Code
PQY  
Date Received08/27/2015
Decision Date 02/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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