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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 electroencephalography (eeg)-driven upper extremity powered exerciser
De Novo Number DEN200046
Device Name Neurolutions Upper Extremity Rehabilitation System
Neurolutions, Inc.
1101 pacific avenue, suite 300
santa cruz,  CA  95060
Contact kern j. bhugra
Regulation Number890.5420
Classification Product Code
Date Received07/23/2020
Decision Date 04/23/2021
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Physical Medicine
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct