Identifiers
- 510(k) Number
- K253241 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 Y207BL is a powered mobility device classified as a Wheelchair, Powered under FDA nomenclature. It is designed to provide independent mobility for users with limited mobility, featuring electric propulsion for ease of maneuvering in indoor and outdoor environments. The device supports weight-bearing users and is engineered for durability and reliability in daily use.
This wheelchair is supplied as a reusable medical device, intended for clinical and home use. It is not sterile upon delivery and requires cleaning and maintenance as specified by the manufacturer. The Y207BL has received FDA 510(k) clearance under the Traditional pathway, classified as Class II, and is regulated under 21 CFR 890.3860. No MRI safety information or specific size variations are noted in the provided data.
Frequently asked questions
What is the Y207BL electric wheelchair designed for?
The Y207BL electric wheelchair is designed to provide independent mobility for users with limited mobility. Its electric propulsion system allows for easy maneuvering in both indoor and outdoor environments, making it suitable for daily use in clinical or home settings. The device is engineered to support weight-bearing users and prioritizes durability and reliability.
Is the Y207BL electric wheelchair sterile when delivered?
No, the Y207BL electric wheelchair is not sterile upon delivery. It is classified as a reusable medical device, meaning it requires cleaning and maintenance as specified by the manufacturer before and after each use. Sterility is not a feature of this product due to its reusable nature.
How is the Y207BL electric wheelchair regulated?
The Y207BL electric wheelchair is regulated under the FDA as a Class II medical device, classified under 21 CFR 890.3860. It has received FDA 510(k) clearance through the Traditional pathway, meaning it has been determined to be substantially equivalent to a legally marketed device already on the market. This classification ensures it meets specific safety and performance standards.
Are there different sizes or models available for the Y207BL?
The provided data does not specify any size variations or distinct model references for the Y207BL electric wheelchair. If customization or specific sizing is required, it would need to be confirmed directly with the manufacturer, Jiangsu Intco Medical Products Co., Ltd.
What maintenance is required for the Y207BL electric wheelchair?
As a reusable device, the Y207BL electric wheelchair requires regular cleaning and maintenance to ensure proper function and longevity. The manufacturer’s guidelines should be followed for cleaning protocols, battery care, and any mechanical checks. Proper maintenance extends the device’s lifespan and ensures safe operation for 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: STAR - INTCO Medical, EASY WAY Y207 Power Wheelchair - INTCO Medical, Jiangsu Intco Medical Products Co., Ltd. FDA 510(k) Products, EASY WAY (Y207) - INTCO Medical, K253241 FDA 510 (k) - Electric Wheelchair (Y207BL)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253241 | Class II | Active |
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Manufacturer
- Manufacturer
- Jiangsu Intco Medical Products Co., Ltd
- FDA Applicant
- Jiangsu Intco Medical Products Co., Ltd.
Sources (1)
- FDA 510(k) K253241 24 fields · synced Oct 1, 2026