Electric Wheelchair Model 9000N
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221799 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 Model 9000N is a powered mobility device designed for individuals with limited mobility. It falls under the category of a Wheelchair, Powered, enabling independent movement for users who require assistance in ambulation.
This device is intended for use in home, clinical, or community settings and is classified as a Class II medical device. Supplied as a reusable unit, it requires proper maintenance and cleaning as per manufacturer guidelines. The Model 9000N has received FDA 510K clearance, MDD, and MDR authorisations, ensuring compliance with regulatory standards for powered wheelchairs.
Frequently asked questions
What types of environments is the Electric Wheelchair Model 9000N designed to be used in?
The Electric Wheelchair Model 9000N is specifically designed for use in home, clinical, and community settings. This versatility ensures it can support individuals with limited mobility in various environments, whether at home, in healthcare facilities, or outdoors in public spaces.
Is the Electric Wheelchair Model 9000N intended for single-use or is it meant to be reused?
The Electric Wheelchair Model 9000N is supplied as a reusable unit. Like all powered mobility devices, it requires regular maintenance and cleaning as outlined by the manufacturer to ensure safe and reliable operation over time.
What regulatory approvals does the Electric Wheelchair Model 9000N hold, and how does this affect its use?
The Electric Wheelchair Model 9000N has received FDA 510K clearance, as well as compliance under the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). These approvals confirm that the device meets regulatory standards for powered wheelchairs, ensuring its safety, performance, and compliance with applicable laws in the markets where it is authorized.
How is the Electric Wheelchair Model 9000N classified, and what does this classification imply for its use?
The Electric Wheelchair Model 9000N is classified as a Class II medical device. This classification implies that it undergoes stricter regulatory oversight compared to Class I devices, ensuring it meets higher safety and performance standards while still being suitable for use in both clinical and home settings for individuals requiring powered mobility assistance.
What maintenance or cleaning procedures should be followed for the Electric Wheelchair Model 9000N?
Since the Electric Wheelchair Model 9000N is a reusable device, proper maintenance and cleaning are essential to ensure its longevity and safe operation. The manufacturer provides specific guidelines for cleaning and upkeep, which should be strictly followed to prevent wear, damage, or hygiene issues. Always refer to the user manual or contact Silver Fox Corporation Limited for detailed instructions.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K221799 | Class II | Active |
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Manufacturer
- Manufacturer
- Silver Fox Corporation Limited
Sources (2)
- FDA 510(k) K221799 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026