Electric Wheelchair (MP201C); Electric Wheelchair (MP201L)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241463 FDA 510(k)
- FDA Product Code
- ITI FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3860 FDA 510(k)
- Regulation Number
- 890.3860 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Electric Wheelchair (MP201C and MP201L) is a powered mobility device designed for individuals with limited mobility. Classified as a Powered Wheelchair under medical nomenclature, it provides motorised propulsion to assist users in indoor and outdoor environments, enhancing independence and mobility.
These devices are intended for single-use or reusable applications in clinical, home, or community settings, depending on configuration. Supplied in non-sterile form, they comply with FDA 510(k) clearance and EU MDR authorisations. The models MP201C and MP201L are regulated under product code ITI, with no third-party involvement. Storage and usage conditions are manufacturer-specified but not detailed in the regulatory data.
Frequently asked questions
Are these electric wheelchairs intended for single-use or can they be reused in clinical settings?
The Electric Wheelchair (MP201C and MP201L) is designed for both single-use and reusable applications, depending on the clinical or user configuration. While the regulatory data does not specify cleaning or reprocessing protocols, the manufacturer’s intended use includes reusable settings, such as home or community use, where durability and repeated use are expected. For clinical reuse, proper cleaning and maintenance per manufacturer guidelines would be required.
What regulatory pathways have these electric wheelchairs followed, and how does that affect their availability?
The Electric Wheelchair (MP201C and MP201L) has obtained FDA 510(k) clearance and EU MDR authorisation, confirming compliance with U.S. and European regulatory standards. This means the devices are legally marketable in the U.S. under FDA regulations and within the EU under MDR requirements. The classification as a Class II device (ITI product code) and the absence of third-party involvement in submissions streamlines distribution but does not alter clinical or functional specifications.
Are these wheelchairs sterile when supplied, and what considerations should be made for storage?
The Electric Wheelchair (MP201C and MP201L) is supplied in a non-sterile form, as explicitly stated in the regulatory data. Storage conditions are manufacturer-specified but not detailed in the provided information. For clinical use, users should follow the manufacturer’s instructions for proper storage to maintain functionality, especially if the device is intended for reuse. Non-sterile devices are typically designed for environments where sterility is not a primary concern, such as home or community settings.
What distinguishes the MP201C and MP201L models, and are there variations in their intended use?
The regulatory data does not provide explicit technical or functional distinctions between the MP201C and MP201L models beyond their classification as electric wheelchairs under the same product code (ITI). Both models fall under the same Powered Wheelchair category and regulatory pathway (FDA 510(k) and EU MDR). Differences, if any, would likely relate to manufacturer-specific configurations (e.g., weight capacity, battery life, or design features), but these are not detailed in the provided data. Clinicians or buyers should consult the manufacturer’s documentation for model-specific details.
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 | K241463 | Class II | Active |
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Manufacturer
- Manufacturer
- Suzhou Master Machinery Manufacturing Co., Ltd
- FDA Applicant
- Suzhou Master Machinery Manufacturing Co.,Ltd
Sources (2)
- FDA 510(k) K241463 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026