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510(k) Data Aggregation
K Number
K212854Device Name
Powered Wheelchair
Manufacturer
Date Cleared
2022-01-10
(124 days)
Product Code
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Qianxi Vehicle Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The XFGW30-107 and XFGW25-203 Powered Wheelchair is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. This product is suitable for disabled people with mobility difficulties and elderly people.
Device Description
The subject device, Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The Powered Wheelchairs consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The XFGW30-107 and XFGW25-203 Powered Wheelchair is intended to provide mobility to a disabled or elderly person limited to a seated position.
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