Wu'S Tech Co., Ltd.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Wu'S Tech Co., Ltd.” (first 2002, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 45 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 | 1 | 291 |
| 2020 | 1 | 483 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Wu'S Tech Co., Ltd. took a median 387 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | 16 | 16 |
| ITI | Wheelchair, Powered | 7 | 7 |
Review panels
- Physical Medicine (23)
Most recent Wu'S Tech Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192308 | Wu's Electrical Scooter | INI | 2020-12-21 | 483 |
| K181163 | Wu's Powered Wheelchair | ITI | 2019-02-16 | 291 |
| K091212 | WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H | INI | 2009-05-27 | 30 |
| K082963 | WU'S 4-WHEELED NEO SCOOTER, WT-M3A | INI | 2008-11-24 | 52 |
| K072337 | WU'S 4-WHEELED NEO SCOOTER, MODEL WT-M4A | INI | 2007-09-21 | 32 |
| K070655 | WU'S POWERED WHEELCHAIR, MAMBO 36 | ITI | 2007-04-02 | 24 |
| K062790 | WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E | INI | 2006-10-11 | 23 |
| K052559 | WU'S POWERED WHEELCHAIR, MAMBO 2 | ITI | 2005-09-26 | 10 |
| K050042 | WU'S 4-WHEELED NEO SCOOTER, WT-XL4 | INI | 2005-03-14 | 66 |
| K050011 | WU'S POWERED WHEELCHAIR, MAMBO F 120 | ITI | 2005-02-11 | 39 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Wu'S Tech 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Wu'S Tech Co., Ltd.?
FDA lists 23 510(k) clearances under the applicant name “Wu'S Tech Co., Ltd.” (first 2002, latest 2020), across 2 product codes 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 Wu'S Tech Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wu'S Tech Co., Ltd. is 45 days.
Which FDA product codes appear under Wu'S Tech Co., Ltd.?
The most frequent FDA product codes under this applicant name are INI (Vehicle, Motorized 3-Wheeled, 16); ITI (Wheelchair, Powered, 7).
Next steps
- See all 23 Wu'S Tech Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code INI, Wu'S Tech 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.