WU'S 4-WHEELED Neo Scooter, WT-M4JR
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K032489 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-M4JR is a motorized mobility vehicle designed to provide transport for individuals with restricted mobility. It functions as a personal transport aid, allowing users to navigate environments while seated and operated via manual controls.
This device is intended for use in indoor and outdoor environments to facilitate independent movement for patients unable to walk. It is a Class II medical device with FDA 510K clearance (K032489) and is regulated under product code INI. The device focuses on mechanical design for stability and seated support.
Frequently asked questions
What is the WU'S 4-Wheeled Neo Scooter used for?
The WU'S 4-Wheeled Neo Scooter is a motorized mobility vehicle designed to provide transport for individuals with restricted mobility. It functions as a personal transport aid, allowing users to navigate both indoor and outdoor environments while seated and operated via manual controls.
What is the regulatory status of this mobility scooter?
The WU'S 4-Wheeled Neo Scooter is a Class II medical device with FDA 510K clearance (K032489) and is regulated under product code INI. It was cleared through the traditional clearance process on September 24, 2003.
How is the WU'S 4-Wheeled Neo Scooter supplied?
The device is supplied as a complete mobility vehicle with manual controls for operation. It is designed for seated use and focuses on mechanical design for stability and support, though specific details about packaging or accessories are not provided in the device data.
Can the WU'S 4-Wheeled Neo Scooter be used both indoors and outdoors?
Yes, the WU'S 4-Wheeled Neo Scooter is intended for use in both indoor and outdoor environments to facilitate independent movement for patients unable to walk. Its design allows for navigation in various settings while providing stability and seated support.
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 K032489 - Wu'S 4-wheeled Neo Scooter, Wt-m4jr, Electric mobility scooter - M4Jr.G - Wu's Tech - 4-wheel / with basket
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032489 | Class II | Active |
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Manufacturer
- Manufacturer
- WU’S Tech Co., Ltd.
- FDA Applicant
- Wu'S Tech Co., Ltd.
Sources (1)
- FDA 510(k) K032489 24 fields · synced Sep 21, 2026