Wu's 4-WHEELED Neo Scooter, WT-M3A
FDA 510(k) K082963 · Wu'S Tech Co., Ltd.
510(k) numberK082963
Submission
- Device name
- Wu's 4-WHEELED Neo Scooter, WT-M3A
- Applicant
- Wu'S Tech Co., Ltd.
Hsin-Chu City, TW - Received
- October 3, 2008
- Decision date
- November 24, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- INI – Vehicle, Motorized 3-Wheeled
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3800
- Specialty
- Physical Medicine
Other 510(k)s with product code INI
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|---|---|---|---|
| K260176 | Mobility Scooter (W3483, W3483A)INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 08/10/2026SE |
| K260094 | Mobility Scooter (W3465, W3902 (S50 Carbon))INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 08/10/2026SE |
| K261232 | IERO Mobility Scooter (IERO-01)INI · Traditional | Jochu Technology Co., Ltd. | 07/14/2026SE |
| K261163 | Mobility Scooter (R200)INI · Traditional | Yongkang Ruihe Metal Product Co., Ltd. | 07/07/2026SE |
| K253257 | Virgo Mobility Scooter (Virgo-D,Virgo-F)INI · Traditional | Jiangsu Intco Medical Products Co., Ltd. | 06/08/2026SE |
| K253600 | Scooter (YD-03)INI · Traditional | Yurob Rehabilitation Medical Co., Ltd. | 06/03/2026SE |
| K260717 | Mobility Scooter (Air Carbon)INI · Traditional | Suzhou Sweetrich Vehicle Industry Technology… | 05/20/2026SE |
| K260237 | Mobility Scooter (X-12, X-14, X-17)INI · Traditional | Wuyi Aichi Industry and Trade Co., Ltd. | 04/22/2026SE |
| K252813 | Electrical Scooter (SM4226)INI · Traditional | Lerado Zhongshan Peaceful Cove Business Trading… | 03/17/2026SE |
| K253936 | Power Mobility Scooter (MJMA01, MJMA02)INI · Traditional | Nanjing Mijo Technology Co., Ltd. | 03/12/2026SE |
More from Nanjing Mijo Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K222729 | Electrical Scooter, WT-T4QP2INI · Traditional | 03/28/2023SE |
| K192308 | Wu's Electrical ScooterINI · Traditional | 12/21/2020SE |
| K181163 | Wu's Powered WheelchairITI · Traditional | 02/16/2019SE |
| K091212 | Wu's 3 Wheeled Electrical Scooter, WT-T3HINI · Traditional | 05/27/2009SE |
| K072337 | Wu's 4-WHEELED Neo Scooter, Model WT-M4AINI · Traditional | 09/21/2007SE |
| K070655 | Wu's Powered Wheelchair, Mambo 36ITI · Traditional | 04/02/2007SE |
| K062790 | Wu's 3-WHEELED Neo Scooter, Model WT-T3EINI · Traditional | 10/11/2006SE |
| K052559 | Wu's Powered Wheelchair, Mambo 2ITI · Traditional | 09/26/2005SE |
| K050042 | Wu's 4-WHEELED Neo Scooter, WT-XL4INI · Traditional | 03/14/2005SE |
| K050011 | Wu's Powered Wheelchair, Mambo F 120ITI · Traditional | 02/11/2005SE |
Questions and answers
When was Wu's 4-WHEELED Neo Scooter, WT-M3A cleared by the FDA?
Wu's 4-WHEELED Neo Scooter, WT-M3A (K082963) received a 510(k) decision of Substantially Equivalent on November 24, 2008, 52 days after the submission was received.
What is the product code of K082963?
The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.