K250096
- 510(k) number
- K250096
- Device name
- Felix NeuroAI System
- Applicant
- Fasikl Incorporated MN · US
- Product code
- QBC — External Upper Limb Tremor Stimulator
- Decision date
- 2025-07-01
- Date received
- 2025-01-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K250096.pdf
Official FDA record: K250096
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.