Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wheelchair & Scooter Express · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
121 daysmedian FDA review time
209 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032441 | F-10 FOLDING POWER CHAIR | Wheelchair & Scooter Express | 2003-10-06 | 60 | 0 |
| K030757 | COACH 777-4 | Wheelchair & Scooter Express | 2003-10-06 | 209 | 0 |
| K030756 | COACH 777-3 | Wheelchair & Scooter Express | 2003-10-06 | 209 | 0 |
| K032440 | F-11 FOLDING POWER CHAIR | Wheelchair & Scooter Express | 2003-09-23 | 47 | 0 |
| K030758 | COACH 888 | Wheelchair & Scooter Express | 2003-07-31 | 142 | 0 |
| K030760 | COACH 888W | Wheelchair & Scooter Express | 2003-07-10 | 121 | 0 |
| K030759 | LITTLE COACH | Wheelchair & Scooter Express | 2003-05-01 | 51 | 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