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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name virtual reality behavioral therapy device for pain relief
De Novo Number DEN210014
Device Name EaseVRx
Requester
appliedvr, inc.
16760 stagg st, ste 216
van nuys,  CA  91406
Contact jafar shenasa
Regulation Number890.5800
Classification Product Code
QRA  
Date Received03/30/2021
Decision Date 11/16/2021
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Physical Medicine
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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