K254004
- 510(k) number
- K254004
- Device name
- VRNT
- Applicant
- Cognifisense, Inc. CA · US
- Product code
- QRA — Virtual Reality Behavioral Therapy Device For Pain R
- Decision date
- 2026-04-10
- Date received
- 2025-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K254004.pdf
Official FDA record: K254004
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.