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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 K251519
Device Name RelieVRx (Pico G3)
Applicant
Appliedvr
16760 St.agg St.
Van Nuys,  CA  91406
Applicant Contact Gabriela Pastushenko
Correspondent
Appliedvr
16760 St.agg St.
Van Nuys,  CA  91406
Correspondent Contact Gabriela Pastushenko
Regulation Number890.5800
Classification Product Code
QRA  
Date Received05/16/2025
Decision Date 08/13/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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