QGL · Class II · 21 CFR 882.5898

FDA Product Code QGL: Transcutaneous Nerve Stimulator For Adhd

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.

Leading manufacturers include Nu Eyne Co., Ltd., Neurosigma, Inc. and Bistos Co., Ltd..

5
Total
4
Cleared
251d
Avg days
2019
Since
Declining activity - 1 submissions in the last 2 years vs 3 in the prior period
Review times improving: avg 90d recently vs 291d historically

FDA 510(k) Cleared Transcutaneous Nerve Stimulator For Adhd Devices (Product Code QGL)

5 devices
1–5 of 5
Cleared Jan 16, 2025
ADDNOX (BPSPM1)
K243289
Nu Eyne Co., Ltd.
Neurology · 90d
Cleared Aug 28, 2024
BT-1000
K232991
Bistos Co., Ltd.
Neurology · 341d
Cleared Jan 16, 2024
Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
K233293
Neurosigma, Inc.
Neurology · 109d
Cleared Feb 12, 2023
SMILE
K213629
Nu Eyne Co., Ltd.
Neurology · 452d
Not Cleared Apr 19, 2019
Monarch eTNS System
DEN180041
Neurosigma, Inc.
Neurology · 263d

About Product Code QGL - Regulatory Context

510(k) Submission Activity

5 total 510(k) submissions under product code QGL since 2019, with 4 receiving FDA clearance (average review time: 251 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - QGL Product Code

Recent submissions under QGL have taken an average of 90 days to reach a decision - down from 291 days historically, suggesting improved FDA processing for this classification.

QGL devices are reviewed by the Neurology panel. Browse all Neurology devices →