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510(k) Data Aggregation

    K Number
    K061514
    Device Name
    BRUNO VERTICAL PLATFORM LIFT, MODEL VPL-3100
    Manufacturer
    BRUNO INDEPENDENT LIVING AIDS, INC.
    Date Cleared
    2006-07-13

    (42 days)

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

    BRUNO VERTICAL PLATFORM LIFT, MODEL VPL-3100

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

    The VPL-3100 is intended to mechanically transport an individual with a mobility disability, either in a wheelchair device or ambulatory, from one level to another in a private residence.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA, specifically concerning the Bruno Vertical Platform Lift, VPL-3100. This type of document is for medical device clearance, not for AI/software device performance studies. Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth for an AI device is not available in this text.

    The document discusses substantial equivalence to predicate devices, general controls, and regulations for market access of the physical elevator device, not the performance of an AI algorithm.

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