Electrically Powered Wheelchair Model YC-01
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K253980 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 Electrically Powered Wheelchair Model YC-01 is a mobility aid classified as a Wheelchair, Powered under FDA nomenclature. It is designed to provide motorised propulsion for individuals with limited mobility, enabling independent movement while seated. The device features battery operation to drive its wheels, allowing users to navigate indoor and outdoor environments with reduced physical effort. Its primary function is to enhance accessibility and autonomy for users reliant on wheelchair assistance.
This device is supplied as a reusable medical aid, intended for long-term use under clinical supervision. It has received FDA 510(k) clearance and MDR authorisation, adhering to regulatory standards for Class II devices under product code ITI. The wheelchair is manufactured by Yurob Rehabilitation Medical Co., Ltd., with specifications aligned to regulation number 890.3860 and medical specialty Physical Medicine. No specific sterility or MRI safety details are provided in the data, but standard maintenance protocols apply for reusable mobility aids.
Frequently asked questions
What is the primary purpose of the Electrically Powered Wheelchair (Model YC-01) and who is it designed for?
The Electrically Powered Wheelchair (Model YC-01) is designed to provide motorized propulsion for individuals with limited mobility, enabling them to move independently while seated. It enhances accessibility and autonomy for users who rely on wheelchair assistance, making navigation easier in both indoor and outdoor environments.
Is the YC-01 wheelchair intended for single-use or long-term reuse, and what maintenance protocols apply?
The YC-01 is supplied as a reusable medical aid intended for long-term use under clinical supervision. Since it is not sterile, standard maintenance protocols for reusable mobility aids apply, though specific cleaning or sterilization instructions are not detailed in the provided data.
What regulatory approvals does the YC-01 wheelchair hold, and which regulatory bodies have authorized it?
The YC-01 has received FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming compliance with regulatory standards for Class II devices under product code ITI. These approvals validate its safety and performance for motorized wheelchair use.
Does the YC-01 come in multiple sizes or models, and if so, how would one determine the appropriate fit?
The provided data does not specify individual sizes or model variations for the YC-01 wheelchair. However, since it is classified under product code ITI and designed for general mobility assistance, manufacturers typically offer customization options based on user height, weight, and specific mobility needs. Consulting with a healthcare professional or the manufacturer would be necessary to determine the best fit.
What medical specialty is associated with the YC-01, and how might this influence its use in clinical settings?
The YC-01 is categorized under the medical specialty of Physical Medicine, indicating its primary use in clinical settings focused on restoring function and mobility for patients with physical disabilities or impairments. Clinicians in this specialty—such as physiatrists or physical therapists—would likely oversee its prescription, fitting, and ongoing use to ensure optimal patient outcomes.
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: Electrically Powered Wheelchair (Model YC-01), K253980 FDA 510(k) - Electrically Powered Wheelchair (Model ..., Electrically Powered Wheelchair (Model YC-01) - BEUDAMED, K253980 FDA 510(k) - Electrically Powered Wheelchair (Model ...
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 | K253980 | Class II | Active |
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Manufacturer
- Manufacturer
- Yurob Rehabilitation Medical Co., Ltd
- FDA Applicant
- Yurob Rehabilitation Medical Co., Ltd.
Sources (2)
- FDA 510(k) K253980 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026