Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fortress Litestyle · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
60 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910751 | FORTRESS 1600ACV REAR WHEEL DRIVE SCOOTER | Fortress Litestyle | 1991-04-22 | 60 | 0 |
| K910753 | FORTRESS MODEL SPIRIT 4-WHEEL POWER WHEELCHAIR | Fortress Litestyle | 1991-04-22 | 60 | 0 |
| K910749 | FORTRESS MODEL 760-V 4 WHEEL POWER WHEELCHAIR | Fortress Litestyle | 1991-04-22 | 60 | 0 |
| K910747 | FORTRESS AEROEDGE 3-WHEEL MANUAL RACING WHEELCHAIR | Fortress Litestyle | 1991-03-21 | 28 | 0 |
| K910748 | FORTRESS EDGE MANUAL RIGID WHEELCHAIR | Fortress Litestyle | 1991-03-05 | 12 | 0 |
| K910750 | FORTRESS CUSTOM MANUAL FOLDING WHEELCHAIR | Fortress Litestyle | 1991-03-05 | 12 | 0 |
| K910752 | FORTRESS LIBERTY MANUAL FOLDING WHEELCHAIR | Fortress Litestyle | 1991-03-05 | 12 | 0 |
| K910746 | FORTRESS FREESTYLE II MANUAL FOLDING WHEELCHAIR | Fortress Litestyle | 1991-03-05 | 12 | 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