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QGT — Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine Class II

FDA Device Classification

Classification Details

Product Code
QGT
Device Class
Class II
Regulation Number
882.5899
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Definition

A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250405theranica bio-electronicsNerivio; Nerivio InfinityMay 14, 2025
K241756theranica bio-electronicsNerivio; NerivioInfinityOctober 8, 2024
K232152theranica bioelectronicsNerivioInfinityNovember 8, 2023
K223169theranica bioelectronicsNerivioFebruary 6, 2023
K203181theranica bioelectronicsNerivio, FGD000075-4.7January 22, 2021
K201824theranica bio-electronicsNerivioOctober 23, 2020
DEN180059theranica bioelectronicsNerivio MigraMay 20, 2019