K241632
- 510(k) number
- K241632
- Device name
- Electrically powered wheelchair
- Applicant
- Kunshan Hi-Fortune Health Products Co., Ltd. CN
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2024-10-16
- Date received
- 2024-06-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
510(k) Summary (official FDA PDF): K241632.pdf
Official FDA record: K241632
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.