QJQ
- Product code
- QJQ
- Device name
- Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5800
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 19 (all years; only the last 3 years are listed here)
FDA classification definition
To provide electrical current to the head to treat insomnia and/or anxiety
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252951 | 2025-12-31 | Neurofield, Inc. | Genesis Sleep | |
| K232253 | 2024-03-27 | Neurovalens Limited | Modius Stress | |
| K230826 | 2023-10-27 | Neurovalens , Ltd. | Modius Sleep |
Official FDA classification page: QJQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).