Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Taiwan Armada Enterprise Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
24 daysmedian FDA review time
49 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K020188 | BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR | Taiwan Armada Enterprise Co., Ltd. | 2002-03-08 | 49 | 0 |
| K020472 | BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIR | Taiwan Armada Enterprise Co., Ltd. | 2002-03-08 | 24 | 0 |
| K020284 | BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR | Taiwan Armada Enterprise Co., Ltd. | 2002-02-08 | 11 | 0 |
| K014198 | BIOTECH B990K VIVI WHEELCHAIR | Taiwan Armada Enterprise Co., Ltd. | 2002-02-01 | 42 | 0 |
| K011701 | BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR | Taiwan Armada Enterprise Co., Ltd. | 2001-06-22 | 21 | 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