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510(k) Data Aggregation

    K Number
    K113621
    Device Name
    SMARTDRIVE WHEELCHAIR POWER-ASSIST
    Manufacturer
    MAX MOBILITY, LLC
    Date Cleared
    2012-07-06

    (211 days)

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

    The SmartDrive is intended to provide power-assist to manual wheelchairs, empowering disabled persons, including pediatrics, capable of operating a powered and manual wheelchair by providing a means of enhanced mobility.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA related to a 510(k) premarket notification for a device called "SmartDrive Wheelchair Power-Assist."

    This letter does not contain any information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for proving the device meets acceptance criteria. It is a regulatory approval letter based on substantial equivalence to a predicate device, not a performance study report.

    Therefore, I cannot fulfill your request based on the provided input.

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