Transcutaneous Nerve Stimulator For Adhd
FDA product code QGL · Class II (moderate risk) · 21 CFR 882.5898 · Neurology
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.
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243289 | Addnox (BPSPM1)QGL · Traditional | Nu Eyne Co., Ltd. | 01/16/2025SE |
| K232991 | BT-1000QGL · Traditional | Bistos Co., Ltd. | 08/28/2024SE |
| K233293 | Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®QGL · Traditional | Neurosigma, Inc. | 01/16/2024SE |
| K213629 | SmileQGL · Traditional | Nu Eyne Co., Ltd. | 02/12/2023SE |