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QGL

Transcutaneous Nerve Stimulator For Adhd

Product code
QGL
Device name
Transcutaneous Nerve Stimulator For Adhd
Device class
Class 2
21 CFR
21 CFR 882.5898
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)
5 (all years; only the last 3 years are listed here)

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.

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: 2025-01-16.

NumberDecision dateApplicantDevice nameSummary
K2432892025-01-16Nu Eyne Co., Ltd.ADDNOX (BPSPM1)PDF
K2329912024-08-28Bistos Co., Ltd.BT-1000PDF
K2332932024-01-16Neurosigma, Inc.Generation 2.0 Monarch external Trigeminal Nerve Sti…PDF

3 summaries are archived here for direct download.

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