Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shanghai Bangbang Robotics Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253276 | Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wh | Shanghai Bangbang Robotics Co., Ltd. | 2026-01-15 | 108 | 0 |
| K240339 | Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wh | Shanghai Bangbang Robotics Co., Ltd. | 2024-07-22 | 168 | 0 |
| K231868 | Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 | Shanghai Bangbang Robotics Co., Ltd. | 2023-10-31 | 127 | 0 |
| K223393 | Electric Wheelchair | Shanghai Bangbang Robotics Co., Ltd. | 2023-03-16 | 128 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda