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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 stimulator, nerve, for restless legs syndrome
De Novo Number DEN220059
Device Name NTX100 Tonic Motor Activation (NTX100 ToMAc) System
Requester
noctrix health, inc.
6700 koll center pkwy, ste 310
pleasanton,  CA  94566
Contact shriram raghunathan
Regulation Number882.5887
Classification Product Code
QWD  
Date Received09/21/2022
Decision Date 04/17/2023
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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