K231508
- 510(k) number
- K231508
- Device name
- Power Wheelchair, W5521
- Applicant
- Zhejiang Innuovo Rehabilitation Devices Co.,Ltd CN
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2023-11-09
- Date received
- 2023-05-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
510(k) Summary (official FDA PDF): K231508.pdf
Official FDA record: K231508
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.