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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 distal transcutaneous electrical stimulator for treatment of acute migraine
De Novo Number DEN180059
Device Name Nerivio Migra
Theranica Bioelectronics ltd
45 hamelakha st. poleg industrial park
netanya,  IL 4250574
Contact alon ironi ironi
Regulation Number882.5899
Classification Product Code
Date Received11/06/2018
Decision Date 05/20/2019
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct