K250576
- 510(k) number
- K250576
- Device name
- Flexx Junior (FLX-J00, FLX-J50)
- Applicant
- Karma Mobility Co, Ltd. TH
- Product code
- IOR — Wheelchair, Mechanical
- Decision date
- 2025-11-04
- Date received
- 2025-02-27
- 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: K250576.pdf
Official FDA record: K250576
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.