K260295
- 510(k) number
- K260295
- Device name
- Helio Kids; Apex P
- Applicant
- Motion Composites CA
- Product code
- IOR — Wheelchair, Mechanical
- Decision date
- 2026-05-28
- Date received
- 2026-01-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K260295.pdf
Official FDA record: K260295
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.