Nerivio Migra

Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

Theranica Bioelectronics Ltd

The following data is part of a De Novo classification by Theranica Bioelectronics Ltd with the FDA for Nerivio Migra.

Pre-market Notification Details

DeNovo IDDEN180059
Device Name:Nerivio Migra
ClassificationDistal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
Applicant Theranica Bioelectronics Ltd 45 Hamelakha St. Poleg Industrial Park Netanya,  IL 4250574
ContactAlon Ironi Ironi
Product CodeQGT  
CFR Regulation Number882.5899 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardNeurology
Classification AdvisoryNeurology
TypeDirect
Date Received2018-11-06
Decision Date2019-05-20
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290017578019 DEN180059 000

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