DeviceClearance

Product code QGT— Neurology

Nerivio

Classification name
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
Device class
Class 2
Regulation
21 CFR 882.5899
Advisory panel
Neurology
Total cleared
7
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QGT under 21 CFR 882.5899, via openFDA

Market context for product code QGT

FDA has cleared 7 devices under product code QGT between 2019 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QGT

Recent clearances under product code QGT

Data sourced from openFDA. This site is unofficial and independent of the FDA.