FDA product code QGL: Transcutaneous Nerve Stimulator For Adhd
QGL is the FDA product code for transcutaneous nerve stimulator for adhd. It is a Class II device, regulated under 21 CFR 882.5898 and reviewed by the Neurology panel. FDA has cleared 4 510(k) submissions under QGL, 4 in the last five years, from 3 different applicants. The average 510(k) review took 248 days (median 225); 158 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Transcutaneous Nerve Stimulator For Adhd |
| Device class | Class II |
| Regulation | 21 CFR 882.5898 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for QGL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 452 |
| 2024 | 2 | 225 |
| 2025 | 1 | 90 |
Compare with all 510(k) review times · Search every QGL clearance
Top QGL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nu Eyne Co., Ltd. | 2 | 2025-01-16 |
| Bistos Co., Ltd. | 1 | 2024-08-28 |
| Neurosigma, Inc. | 1 | 2024-01-16 |
Most recent QGL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243289 | Nu Eyne Co., Ltd. | ADDNOX (BPSPM1) | 2025-01-16 | 90 |
| K232991 | Bistos Co., Ltd. | BT-1000 | 2024-08-28 | 341 |
| K233293 | Neurosigma, Inc. | Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® | 2024-01-16 | 109 |
| K213629 | Nu Eyne Co., Ltd. | SMILE | 2023-02-12 | 452 |
Recalls for QGL devices
openFDA lists no recalls for product code QGL.
Frequently asked questions
What is FDA product code QGL?
QGL is the FDA product code for transcutaneous nerve stimulator for adhd. It is a Class II device, regulated under 21 CFR 882.5898 and reviewed by the Neurology panel.
What device class is QGL?
Class II, regulation 21 CFR 882.5898. Typical premarket route: 510(k).
How long does a 510(k) take for product code QGL?
Across 4 cleared submissions the average was 248 days from receipt to decision (median 225).
Which companies have the most QGL clearances?
Nu Eyne Co., Ltd. (2); Bistos Co., Ltd. (1); Neurosigma, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QGL
- Run a recall and safety report across every QGL manufacturer
- Watch product code QGL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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