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510(k) Data Aggregation

    K Number
    K151199
    Device Name
    SmartDrive Wheelchair Power Assist
    Manufacturer
    MAX MOBILITY, LLC
    Date Cleared
    2015-07-30

    (86 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    K192016,K220213
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SmartDrive MX2 Wheelchair Power Assist is intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users, including pediatrics. It is intended to be used by users capable of operating and maneuvering a powered and manual wheelchair.

    Device Description

    SmartDrive MX2 Wheelchair Power Assist

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for the "Smartdrive MX2 Wheelchair Power Assist" and primarily discusses regulatory compliance and the device's indications for use. It does not detail specific performance metrics, study designs, or results.

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