Electric Wheelchair Panda 10; Electric Wheelchair Panda 12
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K240079 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 Panda 10 and Panda 12 are motorised mobility devices designed for indoor and outdoor use. Classified as Powered Wheelchairs under FDA regulation 21 CFR 890.3860, they provide seated individuals with limited mobility—such as those with disabilities or elderly users—the means to move independently.
These devices are supplied as reusable medical equipment, intended for clinical and home use. They are not sterile and require proper maintenance and cleaning between uses. The Panda 10 and Panda 12 models comply with FDA 510(k) clearance (K240079) and EU MDR authorisation, with no specific MRI safety restrictions stated. Sizes and configurations are determined by model specifications, and storage should follow manufacturer guidelines to ensure durability and safety.
Frequently asked questions
Are the Panda 10 and Panda 12 electric wheelchairs intended for single-use or reusable in clinical or home settings? Why does this matter?
The Panda 10 and Panda 12 electric wheelchairs are designed as reusable medical equipment, not for single-use. This distinction matters because reusable devices require proper maintenance, cleaning, and servicing between uses to ensure safety, functionality, and compliance with infection control protocols in both clinical and home environments.
What regulatory pathways have the Panda 10 and Panda 12 electric wheelchairs followed, and how does this affect their use?
The Panda 10 and Panda 12 have undergone FDA 510(k) clearance (K240079) and EU MDR authorization, confirming they meet U.S. and European regulatory standards for powered wheelchairs. This means they are legally marketable in those regions, but users should always follow manufacturer guidelines for safe operation, maintenance, and storage to comply with regulatory requirements.
Are these electric wheelchairs suitable for use in an MRI environment, and if not, why?
The Panda 10 and Panda 12 do not have explicit MRI safety restrictions mentioned in the available data, but this does not confirm MRI compatibility. Since they are powered mobility devices with electronic components, they should not be taken into an MRI scanner unless certified MRI-safe by the manufacturer. Always verify with the supplier or manufacturer before use in an MRI environment.
How should storage of the Panda 10 and Panda 12 electric wheelchairs be handled to ensure durability and safety?
The manufacturer recommends following their specific storage guidelines to maintain durability and safety. While exact instructions aren’t detailed here, proper storage typically involves keeping the wheelchair in a clean, dry environment, away from extreme temperatures, direct sunlight, and moisture. Avoid overloading or improper stacking, as this could damage the frame, batteries, or controls.
What determines the size or configuration of the Panda 10 and Panda 12 models, and how might this affect their suitability for different users?
The size and configuration of the Panda 10 and Panda 12 models are determined by their model specifications, which likely include variations in weight capacity, seat dimensions, and maneuverability features. These differences ensure compatibility with users of varying sizes, mobility needs, and environments (e.g., indoor vs. outdoor use). Always refer to the manufacturer’s specifications to select the appropriate model for a user’s 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: Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12), Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12) by ..., Electric Wheelchair (Panda 10); Electric Wheelchair… - FDA.report
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 | K240079 | Class II | Active |
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Manufacturer
- Manufacturer
- Suzhou Ideal Medical Co., Ltd.
Sources (2)
- FDA 510(k) K240079 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026