Device Classification Name |
distal transcutaneous electrical stimulator for treatment of acute migraine
|
De Novo Number |
DEN180059 |
Device Name |
Nerivio Migra |
Requester |
theranica bioelectronics ltd |
45 hamelakha st. poleg industrial park |
netanya,
IL
4250574
|
|
Contact |
alon ironi ironi |
|
Regulation Number | 882.5899
|
Classification Product Code |
|
Date Received | 11/06/2018 |
Decision Date | 05/20/2019 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Neurology
|
Review Advisory Committee |
Neurology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
Predetermined Change Control Plan Authorized |
No
|
|
|