510(k) K243289
- Device
- ADDNOX (BPSPM1)
- Applicant
- Nu Eyne Co., Ltd.
- 510(k) number
- K243289
- Product code
- QGL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-01-16
- Date received
- 2024-10-18
- Regulation
- 882.5898
- Classification name
- Transcutaneous Nerve Stimulator For Adhd
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Dahee Kim
- Address
- #608, 28, Digital-Ro 30-Gil, Guro-Gu Seoul KR 08389 08389
FDA Registration Numbers#
- 3015946733
- 3006179052
- 3011845821
Source Documents#
Other 510(k) Records For Product Code QGL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232991 | BT-1000 | Bistos Co., Ltd. | 2024-08-28 |
| K233293 | Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® | Neurosigma, Inc. | 2024-01-16 |
| K213629 | SMILE | Nu Eyne Co., Ltd. | 2023-02-12 |
| DEN180041 | Monarch eTNS System | Neurosigma, Inc. | 2019-04-19 |