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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Virtual Reality Behavioral Therapy Device For Pain Relief
510(k) Number K243417
Device Name RelieVRx
Applicant
AppliedVR
16760 Stagg St
Van Nuys,  CA  91406
Applicant Contact Michael Chibbaro
Correspondent
AppliedVR
16760 Stagg St
Van Nuys,  CA  91406
Correspondent Contact Michael Chibbaro
Regulation Number890.5800
Classification Product Code
QRA  
Date Received11/04/2024
Decision Date 12/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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