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QGT

Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

Product code
QGT
Device name
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
Device class
Class 2
21 CFR
21 CFR 882.5899
Medical specialty
Neurology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
3
Summaries archived here
3 (direct download)
510(k) clearances (all years, FDA)
7 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-05-14.

NumberDecision dateApplicantDevice nameSummary
K2504052025-05-14Theranica Bio-Electronics, Ltd.Nerivio; Nerivio InfinityPDF
K2417562024-10-08Theranica Bio-Electronics, Ltd.Nerivio; NerivioInfinityPDF
K2321522023-11-08Theranica Bioelectronics , Ltd.NerivioInfinityPDF

3 summaries are archived here for direct download.

Official FDA classification page: QGT
Classification and pathway per current FDA publications. Data from openFDA (CC0).