Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dongguan Prestige Sporting Goods Co., Ltd. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
277 daysmedian FDA review time
619 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190737 | Solax Electric Scooter (Models: S204311M, S204161, S204143) | Dongguan Prestige Sporting Goods Co., Ltd. | 2021-05-10 | 780 | 0 |
| K192190 | Solax Electric Scooter | Dongguan Prestige Sporting Goods Co., Ltd. | 2021-04-23 | 619 | 0 |
| K200978 | Electric Wheelchair (Model: S7110) | Dongguan Prestige Sporting Goods Co., Ltd. | 2021-04-16 | 368 | 0 |
| K202632 | Electric wheelchair (S7204/S7205) | Dongguan Prestige Sporting Goods Co., Ltd. | 2021-04-08 | 209 | 0 |
| K201508 | Infrared Thermometer | Dongguan Prestige Sporting Goods Co., Ltd. | 2021-03-09 | 277 | 0 |
| K202549 | Solax Electric Scooter (Model: S202261B) | Dongguan Prestige Sporting Goods Co., Ltd. | 2021-02-26 | 176 | 0 |
| K191897 | Solax Electric Scooter (Models: S3023, S3024, S3025, S3026) | Dongguan Prestige Sporting Goods Co., Ltd. | 2021-02-10 | 575 | 0 |
| K200857 | Electric wheelchair (Model: S7012) | Dongguan Prestige Sporting Goods Co., Ltd. | 2020-12-17 | 260 | 0 |
| K182400 | Solax Powered Wheelchair (Models: S7101, S7103) | Dongguan Prestige Sporting Goods Co., Ltd. | 2020-04-14 | 588 | 0 |
| K182576 | Solax Powered Wheelchair | Dongguan Prestige Sporting Goods Co., Ltd. | 2019-05-21 | 244 | 0 |
| K131302 | SOLAX | Dongguan Prestige Sporting Goods Co., Ltd. | 2013-11-26 | 203 | 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