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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 prescription audiovisual stimulator (avs) for temporary pain relief (adjunctive use)
De Novo Number DEN250005
Device Name Sana Device
Requester
sana health
2051 dogwood st., suite 220
louisville,  CO  80027
Contact richard hanbury
Regulation Number890.5775
Classification Product Code
QYN  
Date Received03/03/2025
Decision Date 01/16/2026
Decision granted (DENG)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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