K231868
- 510(k) number
- K231868
- Device name
- Electric Wheelchair (Robooter E40), Model name: BBR-E40-01
- Applicant
- Shanghai Bangbang Robotics Co., Ltd. CN
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2023-10-31
- Date received
- 2023-06-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
510(k) Summary (official FDA PDF): K231868.pdf
Official FDA record: K231868
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.