De Novo DEN180059

Device
Nerivio Migra
Contact
alon ironi ironi
De Novo number
DEN180059
Product code
QGT
Regulation
882.5899
Classification name
distal transcutaneous electrical stimulator for treatment of acute migraine
Decision
granted (DENG)
Decision date
2019-05-20
Date received
2018-11-06
Classification advisory
Neurology
Review advisory
Neurology
Type
Direct

Current FDA Classification#

Product code
QGT
Device name
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
Medical specialty
Neurology
Device class
2
Regulation
882.5899
Implant
N
Life sustain/support
N