K242358
- 510(k) number
- K242358
- Device name
- Powered wheelchair (mobility robot) (M4, M4U)
- Applicant
- Xsto Co., Ltd. CN
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2025-04-03
- Date received
- 2024-08-08
- 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: K242358
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.