K240105
- 510(k) number
- K240105
- Device name
- Navigator (FMNVG15); Navigator XL (FMNVX06)
- Applicant
- Forcemech International, LLC TX · US
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2024-08-29
- Date received
- 2024-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240105.pdf
Official FDA record: K240105
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.