Data / Medical devices / Taiwan / Wu's Tech Co., Ltd.
Wu's Tech Co., Ltd.: FDA-registered device maker in Hsin-Chu City Hsinchu(County), Taiwan, 10 510(k) clearances
Wu's Tech Co., Ltd. is registered with the FDA (registration 9616873) in Hsin-Chu City Hsinchu(County), Taiwan. It lists 4 device types. The FDA files 10 510(k) clearances under its listings, the newest dated December 21, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9616873
- FEI number
- 3003190528
- Address
- No. 225, Yuan Peir St., Hsin-Chu City Hsinchu(County), Taiwan, 30093
- Owner or operator
- WU'S TECH CO., LTD. (9041713)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- April 12, 2005
- Registered through
- 2027
- Brand names listed
- EURO-TAIWANAISE, EURO-TWIWANAISE, Mambo 2, Power Scooter, WT-T4DK2, WU'S, WU'S Electrical Scooter, WT-M4JKx, WU'S Powered Wheelchair and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 1 | Manufacturer | accessdata.fda.gov |
| Components, Wheelchair | KNN | 1 | Manufacturer | accessdata.fda.gov |
| Vehicle, Motorized 3-Wheeled | INI | 2 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 21, 2020 | K192308 | Wu's Electrical Scooter | INI | Substantially Equivalent | Wu'S Tech Co., Ltd. | accessdata.fda.gov |
| February 16, 2019 | K181163 | Wu's Powered Wheelchair | ITI | Substantially Equivalent | Wu'S Tech Co., Ltd. | accessdata.fda.gov |
| May 27, 2009 | K091212 | WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H | INI | Substantially Equivalent | Wu'S Tech Co., Ltd. | accessdata.fda.gov |
| September 26, 2005 | K052559 | WU'S POWERED WHEELCHAIR, MAMBO 2 | ITI | Substantially Equivalent | Wu'S Tech Co., Ltd. | accessdata.fda.gov |
| February 11, 2005 | K050010 | WU'S POWERED WHEELCHAIR, MAMBO 36X | ITI | Substantially Equivalent | Wu'S Tech Co., Ltd. | accessdata.fda.gov |
| April 30, 2004 | K040968 | WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D | INI | Substantially Equivalent | Wu'S Tech Co., Ltd. | accessdata.fda.gov |
| December 2, 2003 | K032488 | WU'S 3-WHEELED NEO SCOOTER, WT-T3D | INI | Substantially Equivalent | Wu'S Tech Co., Ltd. | accessdata.fda.gov |
| November 10, 2003 | K033032 | WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR | INI | Substantially Equivalent | Wu'S Tech Co., Ltd. | accessdata.fda.gov |
| September 24, 2003 | K032489 | WU'S 4-WHEELED NEO SCOOTER, WT-M4JR | INI | Substantially Equivalent | Wu'S Tech Co., Ltd. | accessdata.fda.gov |
| April 4, 2003 | K030707 | WU'S POWERED WHEELCHAIR, MAMBO 3 | ITI | Substantially Equivalent | Wu'S Tech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Vehicle, Motorized 3-Wheeled
- All makers of Wheelchair, Powered
- All makers of Accessories, Wheelchair
- All makers of Components, Wheelchair
Updated December 21, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.