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510(k) Data Aggregation

    K Number
    K024346
    Device Name
    THE MULTILIFT
    Manufacturer
    SERVICES INDUSTRIELS SAVARIA, INC.
    Date Cleared
    2003-03-04

    (67 days)

    Product Code
    ING
    Regulation Number
    890.3930
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K960739
    Why did this record match?
    Device Name :

    THE MULTILIFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Multilift Vertical Platform Lift is intended to mechanically transport an individual in a wheelchair directly between floors in a private residence.

    Device Description

    The Multilift is similar to other products in commercial distribution. These products, like the Multilift, utilize electrically driven, wall-mounted on self-standing platform units to enable individuals in wheelchairs to travel up and down between floors in a residential or public setting.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth.

    The document is a 510(k) summary for a vertical platform lift (Multilift) and focuses on establishing substantial equivalence to a predicate device (Savaria V-1504 Vertical Platform Lift). It primarily discusses the device's description, intended use, and comparison to the predicate, as well as the FDA's regulatory decision. It does not contain details of a performance study or testing that would typically address the criteria you've outlined.

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