Identifiers
- 510(k) Number
- K202482 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 Y207 Electric Wheelchair is a powered mobility device designed for users who need electric support for daily indoor and outdoor movement. It has a maximum speed of 7 km/h and a travel mileage of 20 km, making it suitable for daily mobility, short-distance travel, and rehabilitation support.
The device is supplied by Jiangsu Intco Medical Products Co., Ltd. and has FDA 510(k) clearance with number K202482, received on August 28, 2020, and decided on March 18, 2021. It is classified as a Class 2 device under product code ITI and is intended for use in physical medicine applications. The device should be selected based on the intended user profile, local safety requirements, and procurement standards.
Frequently asked questions
What is the Y207 Electric Wheelchair designed for?
The Y207 Electric Wheelchair is a powered mobility device designed for users who need electric support for daily indoor and outdoor movement, suitable for daily mobility, short-distance travel, and rehabilitation support.
What are the key specifications of the Y207 Electric Wheelchair?
The Y207 Electric Wheelchair has a maximum speed of 7 km/h and a travel mileage of 20 km, making it suitable for various mobility needs both indoors and outdoors.
What is the regulatory status of the Y207 Electric Wheelchair?
The Y207 Electric Wheelchair has FDA 510(k) clearance with number K202482, received on August 28, 2020, and decided on March 18, 2021. It is classified as a Class 2 device under product code ITI.
How should the Y207 Electric Wheelchair be selected?
The device should be selected based on the intended user profile, local safety requirements, and procurement standards to ensure it meets the specific needs of the user.
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: EASY WAY Y207 Power Wheelchair - INTCO Medical, EASY WAY (Y207) - INTCO Medical, K202482 FDA 510 (k) - Y207 Electric Wheelchair, Y207 Electric Wheelchair (K202482) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202482 | 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) K202482 24 fields · synced Sep 28, 2026