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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interactive Rehabilitation Exercise Devices
510(k) Number K163245
Device Name Virtual Occupational Therapy Application (VOTA)
Applicant
Barron Associates, Inc.
1410 Sachem Place
Suite 202
Charlottesville,  VA  22901
Applicant Contact Bruce G. Wilson
Correspondent
Barron Associates, Inc.
1410 Sachem Place
Suite 202
Charlottesville,  VA  22901
Correspondent Contact Bruce G. Wilson
Regulation Number890.5360
Classification Product Code
LXJ  
Date Received11/18/2016
Decision Date 02/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Clinical Trials NCT02706912
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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