QGL
- 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)
- 5
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.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243289 | 2025-01-16 | Nu Eyne Co., Ltd. | ADDNOX (BPSPM1) | |
| K232991 | 2024-08-28 | Bistos Co., Ltd. | BT-1000 | |
| K233293 | 2024-01-16 | Neurosigma, Inc. | Generation 2.0 Monarch external Trigeminal Nerve Sti |
Official FDA classification page: QGL
Classification and pathway per current FDA publications. Data from openFDA (CC0).