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510(k) Data Aggregation
K Number
K153328Device Name
SUNCO Mechanical Wheelchair, model SKW-9003
Manufacturer
DANYANG SUNCO MACHINERY CO., LTD
Date Cleared
2016-07-20
(244 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
DANYANG SUNCO MACHINERY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Device Description
The SUNCO Mechanical Wheelchair, model SKW-9003 is an 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, and the upholstery fabric meets the EN 1021-1:2006 Furniture --Assessment of ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette & EN 1021-2:2006 Furniture -- Assessment of ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent. The back upholstery material is resistance-ignitability fabric. The removable desk-length armrest and swing-away detachable footrest.
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