K243440
- 510(k) number
- K243440
- Device name
- Electric Wheelchair (HC820N)
- Applicant
- Yongkang Hengyi Vehicle Co., Ltd. CN
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2024-12-19
- Date received
- 2024-11-06
- 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: K243440
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.