Wu's 3-WHEELED Neo Scooter, Model WT-T3E

FDA 510(k) K062790 · Wu'S Tech Co., Ltd.

Substantially Equivalent

510(k) numberK062790

Submission

Device name
Wu's 3-WHEELED Neo Scooter, Model WT-T3E
Applicant
Wu'S Tech Co., Ltd.
Hsin-Chu City, TW
Received
September 18, 2006
Decision date
October 11, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
INI – Vehicle, Motorized 3-Wheeled
Device class
Class II (moderate risk)
Regulation
21 CFR 890.3800
Specialty
Physical Medicine

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More from Nanjing Mijo Technology Co., Ltd.

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K222729Electrical Scooter, WT-T4QP2INI · Traditional 03/28/2023SE
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K181163Wu's Powered WheelchairITI · Traditional 02/16/2019SE
K091212Wu's 3 Wheeled Electrical Scooter, WT-T3HINI · Traditional 05/27/2009SE
K082963Wu's 4-WHEELED Neo Scooter, WT-M3AINI · Traditional 11/24/2008SE
K072337Wu's 4-WHEELED Neo Scooter, Model WT-M4AINI · Traditional 09/21/2007SE
K070655Wu's Powered Wheelchair, Mambo 36ITI · Traditional 04/02/2007SE
K052559Wu's Powered Wheelchair, Mambo 2ITI · Traditional 09/26/2005SE
K050042Wu's 4-WHEELED Neo Scooter, WT-XL4INI · Traditional 03/14/2005SE
K050011Wu's Powered Wheelchair, Mambo F 120ITI · Traditional 02/11/2005SE

Questions and answers

When was Wu's 3-WHEELED Neo Scooter, Model WT-T3E cleared by the FDA?

Wu's 3-WHEELED Neo Scooter, Model WT-T3E (K062790) received a 510(k) decision of Substantially Equivalent on October 11, 2006, 23 days after the submission was received.

What is the product code of K062790?

The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.