Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shanghai Ruike Sports Goods 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) |
|---|---|---|---|---|---|
| K070501 | RUIKE 3421 POWERED WHEELCHAIR | Shanghai Ruike Sports Goods Co., Ltd. | 2007-03-22 | 29 | 0 |
| K062646 | RUIKE, MODEL 3411 | Shanghai Ruike Sports Goods Co., Ltd. | 2007-02-05 | 154 | 0 |
| K062645 | RUIKE, MODEL 3431 | Shanghai Ruike Sports Goods Co., Ltd. | 2006-12-19 | 104 | 0 |
| K062676 | RUIKE, MODEL 3331 | Shanghai Ruike Sports Goods Co., Ltd. | 2006-12-14 | 97 | 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