Electric Wheelchair GY-E001
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K251891 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 GY-E001 is a powered mobility device designed for individuals requiring assistance with ambulation. Classified as a Class II medical device under 21 CFR 890.3860, it provides motorized propulsion to enhance mobility and independence for users with limited mobility.
This device is supplied as a reusable, non-sterile mobility aid intended for use in clinical, home, or community settings. It is regulated under the FDA’s 510(k) clearance (K251891) and the EU’s MDR, with multiple FEI numbers indicating compliance with Chinese regulatory requirements. Available in various configurations, it requires proper maintenance and storage as specified by the manufacturer.
Frequently asked questions
What settings can the Electric Wheelchair (GY-E001) be used in, and how is it supplied?
The Electric Wheelchair (GY-E001) is designed for use in clinical, home, or community environments to assist individuals with limited mobility. It is supplied as a reusable, non-sterile device, meaning it is intended for repeated use by multiple users (with proper cleaning and maintenance) rather than single-patient use or sterile conditions.
Is the Electric Wheelchair (GY-E001) available in different configurations, and how should it be stored?
Yes, the Electric Wheelchair (GY-E001) is available in various configurations to accommodate different user needs. Storage instructions are manufacturer-specific, but generally, it should be kept in a clean, dry environment away from direct sunlight, extreme temperatures, and moisture to ensure proper functionality and longevity.
What regulatory pathways has the Electric Wheelchair (GY-E001) followed, and what does that mean for buyers?
The Electric Wheelchair (GY-E001) has undergone FDA’s 510(k) clearance process (K251891) and complies with the EU’s Medical Device Regulation (MDR). It is also registered in China with multiple FEI numbers, indicating compliance with local regulatory requirements. This means the device has been evaluated for safety and performance in its intended use as a powered mobility aid, though regulatory status does not imply clinical indications.
How do I know if this wheelchair is suitable for my facility’s needs, and what maintenance is required?
The Electric Wheelchair (GY-E001) is classified under 21 CFR 890.3860 as a Class II medical device, intended for motorized propulsion to enhance mobility. Its suitability depends on user-specific requirements like weight capacity, maneuverability, and terrain compatibility—details that should be reviewed with the manufacturer. Since it is reusable, regular maintenance (e.g., battery checks, tire pressure, mechanical inspections) is required as outlined in the manufacturer’s guidelines to ensure safe and reliable operation.
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 September 9, 2025 Shandong Guyue Healthcare Appliance Co., Ltd., K251891 - Electric Wheelchair (GY-E001) - FDA 510 (k), Shandong Guyue Healthcare Appliance Co., Ltd. FDA 510 (k), Electric Wheelchair | 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 | K251891 | Class II | Active |
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Manufacturer
- Manufacturer
- Shandong Guyue Healthcare Appliance Co., Ltd
- FDA Applicant
- Shandong Guyue Healthcare Appliance Co., Ltd.
Sources (2)
- FDA 510(k) K251891 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026