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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 computerized behavioral therapy device for the treatment of fibromyalgia symptoms
De Novo Number DEN220083
Device Name Stanza
Requester
swing therapeutics, inc.
548 market street #63989
san francisco,  CA  94104
Contact michael rosenbluth
Regulation Number882.5804
Classification Product Code
QWI  
Date Received11/21/2022
Decision Date 05/09/2023
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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