Mobility Scooter (Model X-01, X-02)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242975 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 Vehicle, Motorized 3-Wheeled, designed to assist individuals with limited mobility in indoor and outdoor environments. It provides powered propulsion for users who require enhanced mobility support, enabling greater independence in daily activities.
The Mobility Scooter (Models X-01, X-02) is intended for use in physical medicine settings and has received FDA 510(k) clearance under K242975, as well as MDR authorization. It is classified as a Class II device and is supplied as a reusable medical product. No specific sterility or MRI safety information is provided in the data.
Frequently asked questions
What environments is the Mobility Scooter (Models X-01, X-02) designed to operate in?
The Mobility Scooter (Models X-01, X-02) is specifically designed to assist users with limited mobility in both indoor and outdoor settings. This includes environments where powered propulsion can enhance independence for daily activities, such as homes, clinics, and public spaces.
Is the Mobility Scooter (Models X-01, X-02) intended for single-use or reusable applications?
The Mobility Scooter (Models X-01, X-02) is classified as a reusable medical product. This means it is not designed for single-use and is meant to be cleaned and maintained for repeated use in physical medicine settings.
What regulatory pathways has the Mobility Scooter (Models X-01, X-02) followed for approval?
The Mobility Scooter (Models X-01, X-02) has received FDA 510(k) clearance under the number K242975, with a decision date of May 7, 2025. It is also authorized under the Medical Device Regulation (MDR) and is classified as a Class II device, indicating it has undergone a traditional 510(k) review process.
Are there any specific sterility requirements or considerations for the Mobility Scooter (Models X-01, X-02)?
The provided data does not specify any sterility requirements or claims for the Mobility Scooter (Models X-01, X-02). Since it is a reusable device, it is not sterile out-of-the-box and would require cleaning and maintenance between uses in clinical settings.
What is the intended medical specialty or clinical setting for the Mobility Scooter (Models X-01, X-02)?
The Mobility Scooter (Models X-01, X-02) is intended for use in physical medicine settings, as indicated by its classification under the Physical Medicine (PM) advisory committee and product code. This includes clinical environments where mobility assistance is provided to patients.
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: Mobility Scooter (Model X-01, X-02) (K242975) — FDA 510 (k) | Innolitics, K242975 FDA 510 (k) - Mobility Scooter (Model X-01, Mobility Scooter (Model X-01, X-02) — FDA K242975, Wuyi Aichi Industry & Trade Co., Ltd. FDA 510 (k) Products, Mobility Scooter | Medical Device Navigator
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 | K242975 | Class II | Active |
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Manufacturer
- Manufacturer
- Wuyi Aichi Industry & Trade Co., Ltd.
Sources (2)
- FDA 510(k) K242975 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 29, 2026