K232253
- 510(k) number
- K232253
- Device name
- Modius Stress
- Applicant
- Neurovalens Limited GB
- Product code
- QJQ — Cranial Electrotherapy Stimulator To Treat Insomnia
- Decision date
- 2024-03-27
- Date received
- 2023-07-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K232253.pdf
Official FDA record: K232253
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.