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510(k) Data Aggregation

    K Number
    K231315
    Device Name
    Velox Power Chair
    Date Cleared
    2024-01-12

    (252 days)

    Product Code
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Velox Manufacturing Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Velox power wheelchair is a battery operated device that is intended to provide mobility to individuals who lack mobility and who have the capability to operate a power wheelchair while being restricted to the seated position.
    Device Description
    The Velox Power Chair is designed for everyday use for both indoor environments including care facilities and private residences. The subject device is intended to provide mobility to persons that are restricted or limited to a sitting position. The Velox Power Chair is a battery powered, electric motor driven device that can be used on both indoor and outdoor surfaces, on soft/rough terrain. The user controls the speed and direction of the wheelchair using the joystick and hand control buttons mounted on the chair. The brakes of the wheelchair are electromagnetic.
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