Electric Wheelchair MP148
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- Electric wheelchair EUDAMED
- Model / Reference
- MP201C MP201L MP201M EUDAMEDMP201C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974386930012 EUDAMED
- Basic UDI-DI
- 697438693MP201P2 EUDAMED
- 510(k) Number
- K253870 FDA 510(k)
- FDA Product Code
- ITI FDA 510(k)
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3860 FDA 510(k)
- Regulation Number
- 890.3860 FDA 510(k)
- Market of Registration
- Austria EUDAMED
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Electric Wheelchair MP148 is a powered mobility device designed for individuals requiring assistance with ambulation. Classified as a Wheelchair, Powered under FDA nomenclature, it provides motorised propulsion to enhance mobility for users with limited mobility or physical impairments.
This device is intended for use in clinical and home settings, supplied as a reusable medical product. It complies with FDA 510(k) clearance (K253870) and MDR regulations, adhering to 21 CFR 890.3860 for powered wheelchairs. Multiple model variations are listed under registration numbers, confirming regulatory compliance for Class II devices under product code ITI. No specific sterility or MRI safety details are provided.
Frequently asked questions
What types of environments is the Electric Wheelchair (MP148) intended for use in, and how does this affect its maintenance requirements?
The Electric Wheelchair (MP148) is designed for use in both clinical settings (like hospitals or rehabilitation centers) and home environments. Since it is classified as a reusable medical product, it requires regular cleaning and maintenance to ensure hygiene and functionality. Users or caregivers should follow manufacturer guidelines for cleaning protocols, which may include disinfection procedures tailored for reusable mobility devices. Proper maintenance extends the device’s lifespan and ensures safe operation for users with limited mobility.
How many model variations of the Electric Wheelchair (MP148) are registered, and what does this indicate about customization options?
The Electric Wheelchair (MP148) has multiple model variations, with over 70 distinct registration numbers listed under regulatory records. This suggests a range of customization options, likely including differences in specifications such as weight capacity, seating configurations, battery life, or motor power. Buyers should consult the manufacturer or distributor to confirm which variations align with their specific user requirements, such as size, terrain compatibility, or additional features.
Is the Electric Wheelchair (MP148) intended for single-use or reusable purposes, and what does this mean for its care and replacement cycle?
The Electric Wheelchair (MP148) is explicitly described as a reusable medical product, not single-use. This means it is designed for long-term use by individual patients or across multiple users in clinical settings, provided it undergoes proper cleaning, disinfection, and maintenance between uses. Reusability implies a longer replacement cycle compared to disposable devices, but it also requires adherence to hygiene protocols to prevent cross-contamination and ensure safe operation.
What regulatory pathways has the Electric Wheelchair (MP148) followed, and how does this impact its availability or approval status?
The Electric Wheelchair (MP148) has undergone FDA 510(k) clearance (K253870) and complies with MDR (Medical Device Regulation) requirements, adhering to 21 CFR 890.3860 for powered wheelchairs. These pathways confirm its classification as a Class II device under product code ITI, indicating it has met regulatory standards for safety and effectiveness. Availability may vary by region, but the clearance suggests it is legally marketable in the U.S. and EU, subject to local compliance with distribution and labeling requirements.
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: PDF Suzhou Master Machinery Manufacturing Co.,Ltd ℅ Xiang Ariel Senior ..., K253870 - Electric Wheelchair (MP148) | FDA 510 (k), PDF K253870 - Electric Wheelchair (MP148), K253870 - Electric Wheelchair (MP148) | FDA 510 (k)
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 | K253870 | 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) K253870 24 fields · synced Oct 6, 2026
- EUDAMED 5b4d53e8-756b-4515-8cee-d3a56bc0e55c 61 fields · synced Jul 9, 2026