Transcutaneous Nerve Stimulator For Adhd
The Transcutaneous Nerve Stimulator For ADHD is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead to treat Attention Deficit Hyperactivity Disorder (ADHD) symptoms through targeted nerve stimulation. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 882.5898 in the Neurology specialty. The product code is QGL. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QGL
- Device Class
- FDA class 2
- Regulation Number
- 882.5898
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243289 | ADDNOX (BPSPM1) | Jan 16, 2025 | Substantially Equivalent | Nu Eyne Co., Ltd. |
| K232991 | BT-1000 | Aug 28, 2024 | Substantially Equivalent | Bistos Co., Ltd. |
| K233293 | Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® | Jan 16, 2024 | Substantially Equivalent | Neurosigma, Inc. |
| K213629 | SMILE | Feb 12, 2023 | Substantially Equivalent | Nu Eyne Co., Ltd. |
| DEN180041 | Monarch eTNS System | Apr 19, 2019 | Unknown | Neurosigma, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.