K243110
- 510(k) number
- K243110
- Device name
- eFOLDi Navigator Powerchair (STPC-A)
- Applicant
- Suntech UK , Ltd. GB
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2025-05-08
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243110.pdf
Official FDA record: K243110
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.