Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
Device Classification Under Section 513(f)(2)(De Novo)
FDA Home
Medical Devices
Databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
Back to Search Results
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
QGT
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
-
-