K260319
- 510(k) number
- K260319
- Device name
- K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))
- Applicant
- Zhenjiang Assure Medical Equipment Co., Ltd. CN
- Product code
- IOR — Wheelchair, Mechanical
- Decision date
- 2026-03-31
- Date received
- 2026-01-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
510(k) Summary (official FDA PDF): K260319.pdf
Official FDA record: K260319
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.