K232121
- 510(k) number
- K232121
- Device name
- Power wheelchair (Model:BC-EA8000)
- Applicant
- Ningbo Baichen Medical Devices Co., Ltd. CN
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2023-09-15
- Date received
- 2023-07-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232121.pdf
Official FDA record: K232121
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.