Taiwan Armada Enterprise Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Taiwan Armada Enterprise Co., Ltd.” (first 2001, latest 2002), across 1 product code in 1 review panel. Median 510(k) review time under this name: 24 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | 5 | 5 |
Review panels
Most recent Taiwan Armada Enterprise Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020472 | BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIR | IOR | 2002-03-08 | 24 |
| K020188 | BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR | IOR | 2002-03-08 | 49 |
| K020284 | BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR | IOR | 2002-02-08 | 11 |
| K014198 | BIOTECH B990K VIVI WHEELCHAIR | IOR | 2002-02-01 | 42 |
| K011701 | BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR | IOR | 2001-06-22 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Taiwan Armada Enterprise Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Taiwan Aulisa Medical Devices Technologies, Inc. (9 510(k)s)
- Taiwan Surgical Corporation (9 510(k)s)
- Taiwan King Strong Co., Ltd. (4 510(k)s)
- Taiwan Eva Industrial Co., Inc. (3 510(k)s)
- Taiwan Main Orthopaedic Biotechnology Co., Ltd. (3 510(k)s)
- Taiwan an I Co., Ltd. (2 510(k)s)
- Taiwan Biomaterial Co., Ltd. (2 510(k)s)
- Taiwan Link Sdn Bhd (2 510(k)s)
- Taiwan Scientific Corporation (2 510(k)s)
- Taiwan an Lih Ent. Co. , Ltd. (1 510(k)s)
- Taiwan Biophotonic Corporation (1 510(k)s)
- Taiwan Comfort Champ Manufacturing Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Taiwan Armada Enterprise Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Taiwan Armada Enterprise Co., Ltd.” (first 2001, latest 2002), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Taiwan Armada Enterprise Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Taiwan Armada Enterprise Co., Ltd. is 24 days.
Which FDA product codes appear under Taiwan Armada Enterprise Co., Ltd.?
The most frequent FDA product codes under this applicant name are IOR (Wheelchair, Mechanical, 5).
Next steps
- See all 5 Taiwan Armada Enterprise Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IOR, Taiwan Armada Enterprise Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.