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510(k) Data Aggregation
K Number
K152878Device Name
SUNTEC Mechanical Wheelchair, model ST-WL-1000
Manufacturer
Date Cleared
2016-02-03
(126 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
DANYANG SUNTEC AUTO PARTS 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
The SUNTEC Mechanical Wheelchair, model ST-WL-1000 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 Requirements of Section E, Part I for Upholstery Fabrics of California Technical Bulletin CAL 117: 2000 standard for flame retardance.
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