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510(k) Data Aggregation
K Number
K213790Device Name
Aluminum back folding wheelchair SYIV 100-LQXAL2482-407
Manufacturer
Date Cleared
2022-03-14
(98 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
Mobility Source Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Device Description
A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability.
The device is mainly composed of painted frame, fireproof and breathable seat cushion, armrest, backrest, hand push tube, detachable leg, 8-inch front wheel, 24-inch rear wheel, brake group and anti-overturn device.
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