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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 K163393
Device Name Hi-Dow Wireless TENS/EMS System (Model HD-SN)
Hi-Dow International, Inc.
2555 Metro Blvd
Maryland Heights,  MO  63043
Applicant Contact Eric Chen
Benjamin L. England & Associates, LLC
810 Landmark Drive, Suite 126
Glen Burnie,  MD  21061
Correspondent Contact Schevon G. Salmon
Regulation Number882.5890
Classification Product Code
Subsequent Product Code
Date Received12/02/2016
Decision Date 08/04/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No