FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)
K Number: K253276
·
Decision Jan 15, 2026
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
4
Review Days
108
Basic Information
- Device Name
- Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)
- K Number
- K253276
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shanghai Bangbang Robotics Co., Ltd.
- Date Received
- September 29, 2025
- Decision Date
- January 15, 2026
- Product Code
- ITI
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ITI | Wheelchair, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Shanghai Bangbang Robotics Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K240339 | 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) | Jul 22, 2024 | Substantially Equivalent |
| K231868 | Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 | Oct 31, 2023 | Substantially Equivalent |
| K223393 | Electric Wheelchair | Mar 16, 2023 | Substantially Equivalent |