510(k) K223169

Device
Nerivio
Applicant
Theranica Bioelectronics , Ltd.
510(k) number
K223169
Product code
QGT
Decision
Substantially Equivalent
Decision date
2023-02-06
Date received
2022-10-11
Regulation
882.5899
Classification name
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
Medical specialty
Neurology
Review panel
Neurology
Clearance type
Traditional
Third party reviewed
No