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510(k) Data Aggregation

    K Number
    K152827
    Device Name
    Weely Manual Wheelchair
    Manufacturer
    Date Cleared
    2016-02-19

    (143 days)

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

    Rupiani

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indications for use for the Weelchair is to provide mobility to persons limited to a sitting position.
    Device Description
    The Rupiani Weely Manual Wheelchair (Weely) is a manually operated, user propelled, manual, mechanical wheelchair. It's intended function and use is to provide mobility to persons limited to a sitting position. It may also be used in as an attendant propelled transport device in a health care environment such as a hospital, nursing home or extended care facility. The Weely consists primarily of an upper and lower frame assembly, upholstery for seating, large wheels for propelling the chair and rear swivel type pivoting casters for turning. The wheels and casters are mounted to the lower frame assembly. The wheelchair seat and back mount to the upper frame assemblies are constructed from aluminum tubing. The rear casters act as "anti-tippers and provide added stability The lower frame is of rigid (non-folding) design. The back rest can be folded to allow for storage and transport of the chair when it is not in use. The Weely is equipped with a Varilite rigid backrest and a Varilite EVOLUTION cushion covered by SooFleece III mesh fabric provided by Ventex. The upholstery materials meet the requirements of ISO 8191-1 Part 1:Ignition Source: Smoldering Cigarette and - ISO 8191-2 Part 2: Ignition Source: Flame Match-Flame Equivalent Standard for Resistance to Ignition of Upholstered Parts. The Weely includes a tilt mechanism which allows the seat and back of the wheelchair to be tilted. This feature is used to provide comfort to those users who may be confined to the wheelchair for extended periods of time. The tilt mechanism can also serve as an attendant aid in those situations where a patient needs to be tilted for attendant access.
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    K Number
    K992310
    Device Name
    TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4.
    Manufacturer
    Date Cleared
    1999-11-02

    (116 days)

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

    RUPIANI MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    These devices are tricycles that are indicated for use with people, from children to adults, some of whom may have motor disabilities.
    Device Description
    These devices are tricycles
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