Data / Medical devices / Vietnam / WU'S TECH (VIETNAM) Co., Ltd.
WU'S TECH (VIETNAM) Co., Ltd.: FDA-registered device maker in Ho Chi Minh City Binh Duong, Vietnam, 12 510(k) clearances
WU'S TECH (VIETNAM) Co., Ltd. is registered with the FDA (registration 3007963811) in Ho Chi Minh City Binh Duong, Vietnam. It lists 4 device types. The FDA files 12 510(k) clearances under its listings, the newest dated January 8, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007963811
- Address
- No.31, Vsip II, Road 6 Viet Nam -Singapore II Industrial Park, Binh Duong Ward, Ho Chi Minh City Binh Duong, Vietnam, 72200
- Owner or operator
- WU'S TECH CO., LTD. (9041713)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 12, 2005
- Registered through
- 2027
- Brand names listed
- EURO-TAIWANAISE, EURO-TWIWANAISE, Edge 3 / Q6 Edge EM, Electrical Scooter - EURO-TAIWAN; WU'S, Electrical Scooter, WT-T4SU, Go Chair Med / Z-CHAIR, Mambo 2, Power Scooter 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 | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Contract manufacturer, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| January 8, 2025 | K240590 | Electrical Scooter, WT-T4SU | INI | Substantially Equivalent | W'U'S Tech Co., Ltd. | accessdata.fda.gov |
| 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 |
| January 24, 2003 | K023168 | WU'S 3-WHEELED NEO SCOOTER, WT-T3B | INI | Substantially Equivalent | Wu'S Tech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Wheelchair, Powered
- All makers of Vehicle, Motorized 3-Wheeled
- All makers of Components, Wheelchair
- All makers of Accessories, Wheelchair
Updated January 8, 2025. 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.