Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Damaco — 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) |
|---|---|---|---|---|---|
| K970575 | ELECTRO-LITE ELITE POWERED WHEELCHAIR | Damaco | 1997-08-05 | 173 | 0 |
| K894346 | D88VS WHEELCHAIR POWER SYSTEM | Damaco | 1989-08-03 | 20 | 0 |
| K894344 | ELECTRO-LITE POWER WHEELCHAIR | Damaco | 1989-07-28 | 14 | 0 |
| K894345 | ENABLER LIGHTWEIGHT MANUAL WHEELCHAIR | Damaco | 1989-07-27 | 13 | 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