DeviceClearance

Product code QGL— Neurology

ADDNOX (BPSPM1)

Classification name
Transcutaneous Nerve Stimulator For Adhd
Device class
Class 2
Regulation
21 CFR 882.5898
Advisory panel
Neurology
Total cleared
5
First cleared
Most recent

FDA classification definition

“A transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.”

— U.S. Food and Drug Administration, device classification record for product code QGL under 21 CFR 882.5898, via openFDA

Market context for product code QGL

FDA has cleared 5 devices under product code QGL between 2019 and 2025, filed by 3 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 QGL

Recent clearances under product code QGL

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