510(k) DEN180059
- Device
- Nerivio Migra
- Applicant
- Theranica Bioelectronics , Ltd.
- 510(k) number
- DEN180059
- Product code
- QGT
- Decision
- Unknown (DENG)
- Decision date
- 2019-05-20
- Date received
- 2018-11-06
- Regulation
- 882.5899
- Classification name
- Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Alon Ironi Ironi
- Address
- 45 Hamelakha St. Poleg Industrial Park Netanya IL 4250574 4250574
FDA Registration Numbers#
- 3015549449
- 3015379717
- 3035454575
Source Documents#
510(k) summary PDF not indicated by FDA