Wu'S Tech Co., Ltd.
FDA Regulatory Profile
Wu'S Tech Co., Ltd. has 0 FDA recalls, 3 inspections, 23 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Aug 30, 2018 · VAI
- Latest 510(k)
- Dec 21, 2020
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 23 | Oct 4, 2026 | Not stated | Current |
| Inspections | 3 | Oct 23, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Related names
| Name | Recalls | 510(k) | Inspections | Compliance | Most recent recall |
W'u Tech Co Same company group | 0 | 1 | 0 | 0 | — |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
| Aug 30, 2018 | Hsin-Chu, Taiwan | Devices | Voluntary Action Indicated (VAI) | 3003190528 |
| Apr 30, 2015 | Hsin-Chu, Taiwan | Devices | Voluntary Action Indicated (VAI) | 3003190528 |
| Jul 1, 2010 | Hsin-Chu, Taiwan | Devices | Voluntary Action Indicated (VAI) | 3003190528 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
| K192308 | Wu's Electrical Scooter | Dec 21, 2020 |
| K181163 | Wu's Powered Wheelchair | Feb 16, 2019 |
| K091212 | WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H | May 27, 2009 |
| K082963 | WU'S 4-WHEELED NEO SCOOTER, WT-M3A | Nov 24, 2008 |
| K072337 | WU'S 4-WHEELED NEO SCOOTER, MODEL WT-M4A | Sep 21, 2007 |
| K070655 | WU'S POWERED WHEELCHAIR, MAMBO 36 | Apr 2, 2007 |
| K062790 | WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E | Oct 11, 2006 |
| K052559 | WU'S POWERED WHEELCHAIR, MAMBO 2 | Sep 26, 2005 |
| K050042 | WU'S 4-WHEELED NEO SCOOTER, WT-XL4 | Mar 14, 2005 |
| K050010 | WU'S POWERED WHEELCHAIR, MAMBO 36X | Feb 11, 2005 |
| K050011 | WU'S POWERED WHEELCHAIR, MAMBO F 120 | Feb 11, 2005 |
| K040968 | WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D | Apr 30, 2004 |
| K032488 | WU'S 3-WHEELED NEO SCOOTER, WT-T3D | Dec 2, 2003 |
| K032617 | WU'S 4-WHEELED SCOOTER, WT-L4JR | Nov 12, 2003 |
| K033032 | WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR | Nov 10, 2003 |
| K032489 | WU'S 4-WHEELED NEO SCOOTER, WT-M4JR | Sep 24, 2003 |
| K030709 | WU'S POWERED WHEELCHAIR, MAMBO 5 | Apr 4, 2003 |
| K030707 | WU'S POWERED WHEELCHAIR, MAMBO 3 | Apr 4, 2003 |
| K023168 | WU'S 3-WHEELED NEO SCOOTER, WT-T3B | Jan 24, 2003 |
| K023166 | WU'S 3-WHEELED NEO SCOOTER, WT-M4 | Jan 24, 2003 |