Wu's 3 Wheeled Electrical Scooter, Wt-T3h
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K091212 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 3-Wheeled Electrical Scooter WT-T3H is a motorized mobility device designed for physical medicine applications. Classified as a Vehicle, Motorized 3-Wheeled, it provides powered assistance for ambulatory individuals, enhancing mobility and independence in controlled environments.
This device is supplied as a reusable, non-sterile mobility aid intended for use in clinical or home settings. It is regulated under FDA 510K clearance and MDR, with a decision code of SESE (Substantially Equivalent) under the Physical Medicine advisory committee. Multiple registration numbers (e.g., 3033905189) and FEI numbers (e.g., 3006247243) confirm its classification as a Class II device under regulation 890.3800.
Frequently asked questions
What is the primary purpose of the Wu’s 3-Wheeled Electrical Scooter WT-T3H in clinical settings?
The Wu’s 3-Wheeled Electrical Scooter WT-T3H is designed to provide powered mobility assistance for ambulatory individuals, helping them move independently in controlled environments like clinics or homes. It enhances physical mobility for users who require additional support but can still walk with some assistance.
Is the Wu’s 3-Wheeled Electrical Scooter WT-T3H intended for single-use or reusable applications?
The device is explicitly supplied as a reusable mobility aid, meaning it is meant to be used repeatedly by multiple patients or users in clinical or home settings. It is not sterile, so proper cleaning and maintenance are required between uses.
How is the regulatory status of this device classified, and what does that mean for buyers?
The Wu’s 3-Wheeled Electrical Scooter WT-T3H is classified as a Class II device under FDA regulation 890.3800 and has received FDA 510K clearance with a decision labeled *Substantially Equivalent (SESE)*. This means it has been determined to be as safe and effective as a legally marketed device already on the market, ensuring it meets established standards for motorized mobility aids.
Are there multiple models or variations of this scooter, and how can I identify the correct one?
Yes, the device has multiple FEI (Facility Establishment Identifier) numbers and registration numbers listed in regulatory records, indicating variations or configurations may exist. However, the core product is the WT-T3H model, and buyers should verify the exact specifications or contact Wu’s Tech Co., Ltd. for details on size, weight capacity, or other distinguishing features if multiple variants are available.
What storage or maintenance considerations should be kept in mind for the Wu’s 3-Wheeled Electrical Scooter WT-T3H?
Since the scooter is non-sterile and reusable, it requires regular cleaning and maintenance to ensure safe, long-term use. While the data does not specify storage conditions, typical recommendations for motorized mobility devices include keeping it in a dry, temperature-controlled environment away from direct sunlight or moisture to prevent wear or damage to electrical components.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K091212 | Class II | Active |
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Manufacturer
- Manufacturer
- WU’S Tech Co., Ltd.
- FDA Applicant
- Wu'S Tech Co., Ltd.
Sources (2)
- FDA 510(k) K091212 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026