QGL — Transcutaneous Nerve Stimulator For Adhd Class II
Classification Details
- Product Code
- QGL
- Device Class
- Class II
- Regulation Number
- 882.5898
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243289 | nu eyne co | ADDNOX (BPSPM1) | January 16, 2025 |
| K232991 | bistos co | BT-1000 | August 28, 2024 |
| K233293 | neurosigma | Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® | January 16, 2024 |
| K213629 | nu eyne co | SMILE | February 12, 2023 |
| DEN180041 | neurosigma | Monarch eTNS System | April 19, 2019 |