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Wu's 4-WHEELED Neo Scooter, Model WT-T4D

FDA 510(k)

Class II (US FDA 510(k))

510(k) K040968

by WU’S Tech Co., Ltd.

Identifiers

510(k) Number
K040968 FDA 510(k)
FDA Product Code
INI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.3800 FDA 510(k)
Regulation Number
890.3800 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Wu's 4-Wheeled Neo Scooter, Model WT-T4D, is a motorized mobility device classified as a Vehicle, Motorized 3-Wheeled under FDA nomenclature. Designed for individuals requiring enhanced mobility assistance, this scooter provides powered propulsion to support ambulatory patients in indoor and outdoor environments. Its four-wheeled configuration offers improved stability compared to traditional three-wheeled models, making it suitable for varied terrains and user needs.

This device is supplied as a reusable mobility aid, intended for use in clinical and home settings by trained users or caregivers. It is not sterile and requires proper maintenance per manufacturer guidelines. The scooter falls under Regulation Number 890.3800 and has received FDA 510(k) clearance under the Traditional 510(k) review pathway, classified as a Class II device. No specific MRI safety or single-use indications are noted in the regulatory data.

Frequently asked questions

What is the Wu’s Neo Scooter WT-T4D designed for?

The Wu’s Neo Scooter WT-T4D is a motorized mobility device designed to assist individuals with enhanced mobility needs. Its four-wheeled configuration provides improved stability compared to traditional three-wheeled scooters, making it suitable for both indoor and outdoor use. This design supports ambulatory patients who require powered propulsion to navigate varied terrains.

Is the Wu’s Neo Scooter WT-T4D reusable or single-use?

The Wu’s Neo Scooter WT-T4D is supplied as a reusable mobility aid. It is intended for long-term use in clinical and home settings by trained users or caregivers. Proper maintenance per manufacturer guidelines is required to ensure safe and effective operation over time.

Does the Wu’s Neo Scooter WT-T4D come sterile?

No, the Wu’s Neo Scooter WT-T4D is not sterile. It is designed for reusable applications in non-sterile environments, such as home or clinical settings. Sterility is not required for this type of mobility device.

What regulatory pathway does the Wu’s Neo Scooter WT-T4D follow?

The Wu’s Neo Scooter WT-T4D has received FDA 510(k) clearance under the Traditional 510(k) review pathway. It is classified as a Class II device and falls under FDA regulation number 890.3800. The device was determined to be substantially equivalent to a predicate product and is intended for use as a motorized mobility aid.

Are there different sizes or models available for the Wu’s Neo Scooter?

The provided data does not specify multiple sizes or models beyond the WT-T4D designation. However, the device is listed with multiple registration numbers, which may indicate variations in configuration or customization options. For precise details on available sizes or models, refer to the manufacturer’s documentation or contact Wu’s Tech Co., Ltd.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D (K040968) — FDA 510(k ..., WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D - fda.report, PDF a30 2004 C00LTh 0 - accessdata.fda.gov, Wu'S Tech Co., Ltd. - HaRi, Wu'S Tech Co., Ltd. FDA 510(k) Physical Medicine Products 2023

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
WU’S Tech Co., Ltd.
FDA Applicant
Wu'S Tech Co., Ltd.

Sources (1)

  • FDA 510(k) K040968 24 fields · synced Oct 1, 2026