Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Transworld Mobility Distribution, LLC — 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) |
|---|---|---|---|---|---|
| K020001 | PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF- | Transworld Mobility Distribution, LLC | 2002-03-21 | 78 | 0 |
| K020002 | MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , M | Transworld Mobility Distribution, LLC | 2002-03-21 | 78 | 0 |
| K011745 | HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR | Transworld Mobility Distribution, LLC | 2001-08-30 | 85 | 0 |
| K011744 | HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR | Transworld Mobility Distribution, LLC | 2001-08-24 | 80 | 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