Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Free Wheelchair Mission · 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) |
|---|---|---|---|---|---|
| K252370 | GEN 4 JOY Wheelchair | Free Wheelchair Mission | 2026-07-24 | 359 | 0 |
| K170701 | GEN_2 and GEN_3 Mechanical Wheelchairs | Free Wheelchair Mission | 2017-03-24 | 16 | 0 |
| K141691 | GEN_3 | Free Wheelchair Mission | 2014-12-17 | 176 | 0 |
| K113713 | GEN_2 MECHANICAL WHEELCHAIR | Free Wheelchair Mission | 2012-05-07 | 140 | 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