Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Amigo Mobility Intl., Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
211 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101507 | AMIGO CLASSIC FD | Amigo Mobility Intl., Inc. | 2010-07-30 | 59 | 0 |
| K092936 | AMIGO ESCORT 7.5, MODEL 760001 PHS | Amigo Mobility Intl., Inc. | 2009-12-04 | 71 | 0 |
| K010503 | AMIGO WHEELCHAIR | Amigo Mobility Intl., Inc. | 2001-07-06 | 135 | 0 |
| K992619 | AMIGO MODEL 680000 (AMIGO EXCITE F 350) | Amigo Mobility Intl., Inc. | 1999-10-25 | 82 | 0 |
| K983987 | AMIGO MODEL 590000 | Amigo Mobility Intl., Inc. | 1999-06-08 | 211 | 0 |
| K981121 | AMIGO RT | Amigo Mobility Intl., Inc. | 1998-06-30 | 95 | 0 |
| K952112 | AMIGO GRAND TOUR | Amigo Mobility Intl., Inc. | 1995-08-11 | 98 | 0 |
| K940334 | AMIGO J-9 | Amigo Mobility Intl., Inc. | 1994-05-18 | 113 | 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