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Power Wheelchair YH-E6011, YH-E6013A

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250134

by Ningbo Youhuan Automation Technology Co., Ltd.

Identifiers

510(k) Number
K250134 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 Power Wheelchair (YH-E6011, YH-E6013A) is a powered wheelchair designed to provide mobility assistance to individuals. It functions as a motorized transport device for users requiring support for physical movement.

This device is classified under 21 CFR 890.3860 and has received FDA 510(k) clearance. It is identified by the product code ITI and is intended for use within the field of physical medicine.

Frequently asked questions

What is the primary purpose of the YH-E6011 and YH-E6013A Power Wheelchair?

This device is a motorized transport aid designed to provide mobility assistance to individuals who require support for physical movement within the field of physical medicine.

Has this device received regulatory clearance?

Yes, the Power Wheelchair (YH-E6011, YH-E6013A) has received FDA 510(k) clearance under the product code ITI, confirming it is substantially equivalent to legally marketed predicate devices.

Under which regulatory classification does this wheelchair fall?

The device is classified under 21 CFR 890.3860, which pertains to powered wheelchairs used for medical mobility support.

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: Power Wheelchair (YH-E6011,YH-E6013A) (K250134) — FDA 510(k ..., Power Wheelchair (YH-E6011,YH-E6013A) 510 (k) K250134 - FDA.report, K250134 FDA 510 (k) - Power Wheelchair (YH-E6011

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ningbo Youhuan Automation Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K250134 24 fields · synced Sep 27, 2026