Electric Wheelchair (DH01168)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K251458 FDA 510(k)
- FDA Product Code
- ITI FDA 510(k)
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 (DH01168) is a powered mobility device designed to assist individuals with limited mobility in independent movement. Classified as a Class II medical device, it provides electric propulsion for users who require assistance in navigating indoor and outdoor environments without manual effort.
This device is intended for use in clinical and home settings, supplied as a reusable, non-sterile product. It is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), with multiple FEI numbers indicating compliance with regulatory requirements. The wheelchair is available in various configurations, as denoted by the listed registration numbers, and must be operated in accordance with manufacturer guidelines for safety and functionality.
Frequently asked questions
What types of environments is this electric wheelchair designed to operate in and how does that affect its use?
The Electric Wheelchair (DH01168) is specifically designed for use in both clinical settings, such as hospitals or rehabilitation centers, and home environments. Its electric propulsion system enables users with limited mobility to navigate indoor spaces like hallways, rooms, and outdoor areas such as sidewalks or driveways without requiring manual effort. This versatility makes it suitable for individuals who need assistance in transitioning between these environments seamlessly.
Is this wheelchair intended for single-use or can it be reused? How does that impact maintenance and cleaning?
The Electric Wheelchair (DH01168) is supplied as a reusable device, not intended for single-use. Since it is non-sterile, proper maintenance and cleaning protocols must be followed as outlined by the manufacturer to ensure safety, functionality, and longevity. Regular cleaning and periodic inspections are essential to maintain its performance and hygiene, particularly in shared or clinical settings.
What regulatory pathways has this device undergone, and what does that mean for its compliance and use?
The Electric Wheelchair (DH01168) has undergone FDA 510(k) clearance and compliance with the EU Medical Device Regulation (MDR). The device is classified as a Class II medical device, indicating it has undergone rigorous review to ensure its safety and effectiveness. The multiple FEI numbers listed correspond to regulatory compliance in various markets, ensuring it meets the necessary standards for distribution and use in those regions.
Are there different configurations or models available for this wheelchair, and how might that affect selection?
Yes, the Electric Wheelchair (DH01168) is available in various configurations, as indicated by the multiple registration numbers (e.g., 9615350, 3014522447, etc.). These configurations likely cater to different user needs, such as weight capacity, seating adjustments, or additional features like reclining or elevated leg rests. When selecting a model, it’s important to consider the specific mobility requirements of the user to ensure the chosen configuration provides optimal support and comfort.
How should this wheelchair be stored to maintain its functionality and safety over time?
Since the Electric Wheelchair (DH01168) is a reusable, non-sterile device, it should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, and moisture to prevent damage to its components. The manufacturer’s guidelines should be followed for proper storage, including ensuring the battery is either fully charged or stored according to specific instructions to avoid degradation. Regular checks for wear and tear are also recommended to maintain safety and functionality.
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: Electricity: what it is, types, characteristics, and examples
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 | K251458 | Class II | Active |
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Manufacturer
- Manufacturer
- Foshan Dahao Medical Technology Co., Ltd.
- FDA Applicant
- Foshan Dahao Medical Technology Co., Ltd.
Sources (2)
- FDA 510(k) K251458 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026