K243970
- 510(k) number
- K243970
- Device name
- Portable Wheelchair
- Applicant
- Intradin (Shanghai) Machinery Co., Ltd. CN
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2025-03-07
- Date received
- 2024-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K243970
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.