510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QGLClass II

Transcutaneous Nerve Stimulator For Adhd

21 CFR 882.5898 / Neurology
FDA source (opens on fda.gov)

QGL is the FDA product code for Transcutaneous Nerve Stimulator For Adhd, a class II device type, regulated under 21 CFR 882.5898. FDA's definition for this code reads: "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". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QGL
Device name
Transcutaneous Nerve Stimulator For Adhd
FDA 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.
Regulation
21 CFR 882.5898
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code QGL

By decision year
5 clearances under product code QGL with a decision year between 2019 and 2025, 2024 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QGL by decision year
YearClearances
20191
20231
20242
20251

Applicants with the most clearances

Product code QGL
Applicants holding the most 510(k) clearances under product code QGL
ApplicantClearances
Neurosigma, Inc.2
NU Eyne Co., Ltd.2
Bistos co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code