Electric Wheelchair AL-208S-063
by Zhongshan A&J Medical Equipment Co., Ltd. EUDAMED510(k)
Active
510(k) K253340
Overview
The Electric Wheelchair AL-208S-063 is a powered mobility device designed for individuals requiring assistance with ambulation. Classified as a Class II medical device, it is intended to provide independent movement for users with limited mobility, enhancing their ability to navigate indoor and outdoor environments safely and efficiently.
This device is supplied as a reusable mobility aid, intended for use in clinical, home, or community settings. It is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), with a traditional review pathway through the Physical Medicine advisory committee. The wheelchair’s specifications include multiple FEI numbers, indicating compliance with regulatory requirements for powered wheelchairs. Storage and maintenance should follow manufacturer guidelines to ensure optimal performance and longevity.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK253340 | Date3 Apr 2026 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- ITI
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3860
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
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Questions
Is this electric wheelchair designed for single-use or can it be reused over time?
The Electric Wheelchair (AL-208S-063) is explicitly supplied as a reusable mobility aid, intended for use in clinical, home, or community settings. Since it is classified as a reusable medical device, proper storage and maintenance per manufacturer guidelines are required to ensure durability and safe operation over extended periods.
What regulatory pathways were followed for this device’s approval in the U.S. and EU?
The Electric Wheelchair (AL-208S-063) was cleared through the FDA 510(k) pathway under a traditional review, with the Physical Medicine advisory committee (PM) involved. In the EU, it complies with the Medical Device Regulation (MDR). Both routes confirm its classification as a Class II device, ensuring compliance with stringent regulatory requirements for powered mobility aids.
How do I determine if this wheelchair meets the necessary safety and performance standards?
The device’s compliance with regulatory standards is evidenced by its multiple FEI numbers (e.g., 3014522447, 3021071770, etc.) and its classification under FDA regulation number 890.3860 for powered wheelchairs. These identifiers confirm adherence to U.S. and EU safety and performance requirements, though final verification should align with manufacturer-provided documentation.
Is this wheelchair suitable for both indoor and outdoor use, and what factors should I consider?
Yes, the Electric Wheelchair (AL-208S-063) is designed for indoor and outdoor environments, enhancing independent mobility for users with limited ambulation. However, outdoor use may require additional considerations such as terrain compatibility, weather resistance, and battery life—factors that should be evaluated based on the manufacturer’s specifications and environmental conditions.
How can I verify the authenticity of this wheelchair’s regulatory compliance?
Authenticity can be confirmed by checking the registration number (9615350) and product code (ITI) listed in regulatory databases. Additionally, the device’s FDA 510(k) clearance (K253340) and MDR compliance are documented in official submissions. Always cross-reference these details with the manufacturer’s documentation or regulatory portals to ensure legitimacy.