K252951
- 510(k) number
- K252951
- Device name
- Genesis Sleep
- Applicant
- Neurofield, Inc. CA · US
- Product code
- QJQ — Cranial Electrotherapy Stimulator To Treat Insomnia
- Decision date
- 2025-12-31
- Date received
- 2025-09-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252951.pdf
Official FDA record: K252951
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.