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 ID: DEN180059
• Device Name: Nerivio Migra
• Classification: Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
• Applicant: Theranica Bioelectronics Ltd 45 Hamelakha St. Poleg Industrial Park Netanya, IL 4250574
• Contact: Alon Ironi Ironi
• Product Code: QGT
• CFR Regulation Number: 882.5899 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device 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 Board: Neurology
• Classification Advisory: Neurology
• Type: Direct
• Date Received: 2018-11-06
• Decision Date: 2019-05-20
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290017578019	DEN180059	000