K240339
- 510(k) number
- K240339
- Device name
- Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08)
- Applicant
- Shanghai Bangbang Robotics Co., Ltd. CN
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2024-07-22
- Date received
- 2024-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
510(k) Summary (official FDA PDF): K240339.pdf
Official FDA record: K240339
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.