Mobility Scooter - X-14
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K260237 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)
This device is a Motorized 3-Wheeled Vehicle, designed to assist individuals with limited mobility in indoor and outdoor environments. It provides powered propulsion for users who require enhanced mobility support, enabling independent travel over short to moderate distances with minimal physical effort.
The Mobility Scooter X-12, X-14, and X-17 are supplied as reusable, non-sterile medical devices intended for use in home, community, and clinical settings. Each model is classified as Class II under FDA regulations and has received FDA 510K clearance and MDR authorization. Storage requirements are standard for powered mobility devices, and no specific MRI safety restrictions are noted for these models.
Frequently asked questions
What environments is the Mobility Scooter (X-12, X-14, X-17) designed to operate in and what are its primary use cases?
The Mobility Scooter (X-12, X-14, X-17) is specifically designed for indoor and outdoor use, providing powered propulsion to assist individuals with limited mobility. It is intended for home, community, and clinical settings, enabling users to travel short to moderate distances with minimal physical effort. This makes it suitable for daily activities such as navigating homes, shopping centers, or healthcare facilities.
Are these scooters single-use or reusable, and what are the sterility requirements?
The Mobility Scooter (X-12, X-14, X-17) is supplied as a reusable device and is explicitly noted as non-sterile. Since it is intended for multiple uses across various environments, it does not require sterile packaging or handling, but standard hygiene practices should be followed to ensure safe and prolonged use.
What storage requirements should be followed for these scooters?
The Mobility Scooter (X-12, X-14, X-17) follows standard storage requirements for powered mobility devices. While no specific MRI safety restrictions are mentioned, it is important to store the scooter in a dry, well-ventilated area, away from direct sunlight or extreme temperatures, to maintain its functionality and longevity. Always refer to the manufacturer’s guidelines for detailed storage instructions.
How do I determine which model (X-12, X-14, or X-17) is best suited for my needs?
The specific differences between the X-12, X-14, and X-17 models are not detailed in the provided data. However, these models are all classified as Motorized 3-Wheeled Vehicles and are designed for similar purposes. To determine the best fit, consider factors like user weight capacity, travel distance, and terrain requirements. Consulting the manufacturer’s specifications or a healthcare professional familiar with mobility aids can help in selecting the most appropriate model for your needs.
What regulatory pathways have these scooters undergone, and what does that mean for their use?
The Mobility Scooter (X-12, X-14, X-17) has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) authorization. This indicates that the devices have been evaluated for substantial equivalence to existing devices and meet regulatory standards for safety and performance. The classification as Class II under FDA regulations suggests that they undergo additional controls beyond general controls, ensuring higher scrutiny for their design, manufacturing, and post-market surveillance.
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 | K260237 | Class II | Active |
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Manufacturer
- Manufacturer
- Wuyi Aichi Industry & Trade Co., Ltd.
- FDA Applicant
- Wuyi Aichi Industry and Trade Co., Ltd.
Sources (2)
- FDA 510(k) K260237 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026