Electric Wheelchair YFWB-63
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241154 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 YFWB-63 is a Powered Wheelchair, a motor-driven mobility device designed to assist individuals with limited mobility—such as those with disabilities or elderly users—by providing indoor and outdoor transportation. It falls under the Wheelchair, Powered nomenclature and is classified as a Class 2 device under FDA regulation 890.3860, intended for seated use in physical medicine applications.
This device is supplied as a reusable, non-sterile medical product, with no specific MRI safety labeling indicated in the data. It is regulated under the Traditional 510(k) pathway with FDA 510(k) clearance (K241154) and MDR compliance, following a 63-day review by the Physical Medicine Advisory Committee. The model number YFWB-63 is included in multiple registration records, confirming its authorized distribution for mobility assistance.
Frequently asked questions
What is the primary use case for the Electric Wheelchair (YFWB-63) and who is it designed for?
The Electric Wheelchair (YFWB-63) is designed for individuals with limited mobility, including those with disabilities or elderly users, to provide indoor and outdoor transportation. It is classified under the Wheelchair, Powered category and is intended for seated use in physical medicine applications, assisting users who require motorized mobility assistance.
Is the Electric Wheelchair (YFWB-63) a single-use or reusable device, and what does that mean for maintenance?
The Electric Wheelchair (YFWB-63) is a reusable device, meaning it is not intended for single-use disposal. This implies that it must be cleaned, inspected, and maintained according to manufacturer guidelines to ensure safe and reliable operation over time. Reusable devices typically require regular upkeep to prevent wear and tear, which is especially important for mobility aids used daily.
How is the Electric Wheelchair (YFWB-63) regulated, and what does that process entail?
The Electric Wheelchair (YFWB-63) is regulated under the FDA’s Traditional 510(k) pathway and complies with the Medical Device Regulation (MDR). It received FDA 510(k) clearance (K241154) after a 63-day review by the Physical Medicine Advisory Committee, confirming it is substantially equivalent to a legally marketed predicate device. This process ensures the device meets safety and performance standards for powered wheelchairs under FDA classification 890.3860.
Are there any specific storage requirements for the Electric Wheelchair (YFWB-63), and how should it be handled?
While the provided data does not specify exact storage conditions, reusable medical devices like the Electric Wheelchair (YFWB-63) generally require clean, dry storage away from direct sunlight, extreme temperatures, or moisture to prevent damage. Since it is non-sterile, it does not require sterile storage but should be kept in a condition that maintains its functionality and hygiene for safe use.
What does the inclusion of multiple registration numbers (e.g., 9615350, 3014522447) indicate about the Electric Wheelchair (YFWB-63)?
The multiple registration numbers listed for the Electric Wheelchair (YFWB-63) indicate that this model has been authorized for distribution across various facilities or jurisdictions. These numbers confirm the device’s compliance with regulatory requirements and its authorized presence in the market, ensuring traceability and legitimacy for healthcare providers, distributors, and users.
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 (YFWB-63) (K241154) — FDA 510 (k) | Innolitics, K241154 - Electric Wheelchair (YFWB-63) | FDA 510 (k), Electric Wheelchair (YFWB-63) 510 (k) K241154 - 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 | K241154 | Class II | Active |
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Manufacturer
- Manufacturer
- IF Health (Xiamen) Intelligent Technology Co., Ltd
- FDA Applicant
- If Health (Xiamen) Intelligent Technology Co.,Ltd
Sources (2)
- FDA 510(k) K241154 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026