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510(k) Data Aggregation

    K Number
    K132257
    Device Name
    MANUAL WHEELCHAIR
    Manufacturer
    ZHEJIANG JIAFENG ELECTRICAL & MECHANIAL CO., LTD
    Date Cleared
    2014-02-13

    (209 days)

    Product Code
    IOR, MAN
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    **ZHEJIANG JIAFENG ELECTRICAL **& MECHANIAL CO

    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. It is designed for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and packed dirt) that are free of large obstacles and inclines greater than 8 degrees.
    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 Manual Wheelchairs Model SY 100-MA02 (02A & 02B) and Model SY 100-MA06 (or other clients private labeling) are user propelled, manually operated folding wheelchairs that are indicated for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and packed dirt) that are free of large obstacles and inclines greater than 8 degrees. Each consists of four wheels, a mechanical steel frame and nylon upholstery that is ignition resistant. The device is designed to be lightweight and foldable, and can be dissembled. In both models, both rear and caster wheels use solid tires. The model SY100-MA02 has two sub-models (02A & 02B) which both has a physical dimension of 1025 (depth) x 661 (width) x 920 (height) mm, with the seat itself has a dimension of 408 (depth) x 440 (width) x 455 (height) mm. The device has a weight capacity of 130 kilograms. Sub-model MA02A uses hard plastic back wheels and weighs approximately 16.5 kilograms. Sub-model MA02B uses wired steel wheels and weighs 13.8 kilograms. Both sub-models are dark green in color. Model SY100-MA06 has a physical dimension of 1026 (depth) x 651 (width) x 860 (height) mm. with the seat itself has a dimension of 394 (depth) x 374 (width) x 482 (height) mm, and a weight capacity of 100 kilograms, and weighs approximately 15.2 kilograms.
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