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., Bistos Co., Ltd. and Neurosigma, Inc..
FDA 510(k) Cleared Transcutaneous Nerve Stimulator For Adhd Devices (Product Code QGL)
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 remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under QGL have taken an average of 216 days to reach a decision - down from 275 days historically, suggesting improved FDA processing for this classification.
QGL devices are reviewed by the Neurology panel. Browse all Neurology devices →