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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 transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms
De Novo Number DEN210046
Device Name Quell-FM
Requester
NeuroMetrix, Inc.
4b gill street
woburn,  MA  01801
Contact shai gozani
Regulation Number882.5888
Classification Product Code
QSQ  
Date Received10/05/2021
Decision Date 05/18/2022
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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