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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 K192234
Device Name ActiPatch
Applicant
Bioelectronics Corporation
4539 Metropolitan Ct.
Frederick,  MD  21704
Applicant Contact Sree N. Koneru
Correspondent
Bioelectronics Corporation
4539 Metropolitan Ct.
Frederick,  MD  21704
Correspondent Contact Sree N. Koneru
Regulation Number890.5290
Classification Product Code
PQY  
Date Received08/19/2019
Decision Date 01/31/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Clinical Trials NCT03542955
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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