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Wu's 4-WHEELED Neo Scooter WT-L4

FDA 510(k)

Class II (US FDA 510(k))

510(k) K013763

by WU’S Tech Co., Ltd.

Identifiers

510(k) Number
K013763 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 WT-L4 is a motorized mobility vehicle classified as a motorized three-wheeled vehicle. It is designed to assist individuals with restricted mobility by providing seated transport, enabling independent movement in both indoor and outdoor environments. The device prioritizes stability and seated support to enhance user safety and comfort during operation.

This device is intended for single-use or reusable applications in physical medicine settings, as classified under FDA regulation 890.3800. It is supplied as a Class II medical device with a traditional 510(k) clearance, ensuring compliance with regulatory standards. The WT-L4 is operated via manual controls and does not require special storage conditions, though proper maintenance is recommended for longevity and safety.

Frequently asked questions

What is the Wu’s Neo Scooter WT-L4 designed for?

The WT-L4 is a motorized mobility vehicle designed to assist individuals with restricted mobility by providing seated transport. It is intended for use in both indoor and outdoor environments, offering stability and support to enhance user safety and comfort during operation. This makes it suitable for physical medicine settings where independent movement is needed.

Is the WT-L4 intended for single-use or reusable applications?

The WT-L4 is classified under FDA regulation 890.3800 for use in both single-use and reusable applications within physical medicine settings. While it can be reused, proper maintenance is recommended to ensure longevity and safety, as outlined in the device’s specifications.

What type of controls does the WT-L4 use, and does it require special storage?

The WT-L4 is operated via manual controls, meaning it does not rely on automated systems. It does not require special storage conditions, such as temperature control or humidity regulation. However, routine maintenance is advised to preserve functionality and ensure safe operation over time.

What regulatory clearance does the WT-L4 hold?

The WT-L4 holds FDA 510(k) clearance, classified as a Class II medical device. It was granted a traditional 510(k) clearance with a decision of Substantially Equivalent (SESE) by the Physical Medicine Advisory Committee, ensuring compliance with U.S. regulatory standards for motorized mobility vehicles.

What are the key specifications or features that distinguish the WT-L4?

The WT-L4 is a motorized three-wheeled vehicle, though it is marketed as a four-wheeled scooter for enhanced stability. It is designed with seated support to improve user safety and comfort. The device is lightweight and portable, making it suitable for both indoor and outdoor use. Its manual controls and lack of special storage requirements further simplify its integration into clinical or home settings.

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, WT-L4 - Innolitics, WU'S 4-WHEELED NEO SCOOTER, WT-M4JR - Innolitics, PDF Wu's Tech Company, LTD. - Food and Drug Administration

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) K013763 24 fields · synced Oct 1, 2026