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510(k) Data Aggregation
K Number
K190534Device Name
Manual Wheelchair SIVFH2A102
Date Cleared
2019-05-29
(86 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
**Jiangsu Horizon Medical Science **& Technology Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Manual Wheelchair is to provide mobility to persons restricted to a sitting position.
Device Description
The Aluminum Manual Wheelchair is indoor/outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat.
Main components:
Main frame, handle sleeve, back upholstery, seat upholstery, armrest, side panel, rear wheel with handle ring, rear wheel axle, legrest, footplate, front fork, front wheels, cross bar.
Main materials:
Main frame, cross bar, legrest: Aluminum, silver/blue coating
Back upholstery, seat upholstery: Cover is polyester non-woven, inside with flame resistant foam
Handle sleeve, handle sleeve, side panel, handle ring, footplate: PVC
Tire of rear wheels, front wheels, armrest pad: PU
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