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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K192746
Device Name MyoWorx TM20
Applicant
Myoworx, Inc.
201-77 Westmount Rd., Suite 201
Guelph,  CA N1H 5J1
Applicant Contact Bert Oucharek
Correspondent
Dp Distribution & Consulting, LLC
12240 Hunting Horn Lane
Rockville,  VA  23146
Correspondent Contact Darren Reeves
Regulation Number890.5850
Classification Product Code
IPF  
Date Received09/30/2019
Decision Date 10/19/2021
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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