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510(k) Data Aggregation

    K Number
    K242430
    Device Name
    Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820)
    Manufacturer
    Date Cleared
    2024-11-12

    (89 days)

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

    Soul Mobility

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Power-Flex by Soul Mobility is intended to provide enhanced mobility to disabled persons who are capable of operating a powered and manual wheelchair, by providing powered mobility to manual wheelchairs.
    Device Description
    Power-Flex is a power-assist drive that can be attached to a manual wheelchair frame, which enables a manual wheelchair to perform like an electrical wheelchair. The Power-Flex drive system includes two drive wheels, two caster wheels for stability, batteries, a control unit, a power supply and a manual tilt mechanism which also acts as an anti-tip preventative. The Power-Flex connects via the manual chair frame standard axle receivers and the rear manual tilt clamp which attaches to the rear rigidizer bar of the manual wheelchair. The manual wheelchair and frame are not part of the drive system and is provided by the customer. The control unit is the steering device of the system
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