QGL
5 FDA 510(k) clearances · Product code
263 daysmedian time to decision
452 days90th percentile
5clearances measured
FDA profile
- Official device name
- Transcutaneous Nerve Stimulator For Adhd
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5898
- Medical specialty
- Neurology
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ADDNOX (BPSPM1) (K243289) | Nu Eyne Co., Ltd. | 2025-01-16 |
| BT-1000 (K232991) | Bistos Co., Ltd. | 2024-08-28 |
| Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® (K233293) | Neurosigma, Inc. | 2024-01-16 |
| SMILE (K213629) | Nu Eyne Co., Ltd. | 2023-02-12 |
| Monarch eTNS System (DEN180041) | Neurosigma, Inc. | 2019-04-19 |
Track QGL automatically
Every clearance here is in the API, with alerts when new ones post.