Electrical Scooter, WT-T4QP2

FDA 510(k) K222729 · Wu’S Tech Co., Ltd.

Substantially Equivalent

510(k) numberK222729

Submission

Device name
Electrical Scooter, WT-T4QP2
Applicant
Wu’S Tech Co., Ltd.
Hsin-Chu City, TW
Received
September 8, 2022
Decision date
March 28, 2023
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.

510(k)DeviceDecision
K192308Wu's Electrical ScooterINI · Traditional 12/21/2020SE
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
K062790Wu's 3-WHEELED Neo Scooter, Model WT-T3EINI · Traditional 10/11/2006SE
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 Electrical Scooter, WT-T4QP2 cleared by the FDA?

Electrical Scooter, WT-T4QP2 (K222729) received a 510(k) decision of Substantially Equivalent on March 28, 2023, 201 days after the submission was received.

What is the product code of K222729?

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