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510(k) Data Aggregation

    K Number
    K061116
    Device Name
    MOBILLIFE - MODEL (MOBIL RAIZER 22) - POWER WHEELCHAIR
    Manufacturer
    MOBILIFE, LLC
    Date Cleared
    2006-07-03

    (73 days)

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

    The mobilitie Model ( Mobil Raizer 22) Power Wheelchair The mobile to inback or powered personal mobility clectric wheel chair with a sent cupable to be raised 22 inch designed for an adult occupant that wrighs up to 215 pounds (depending on seating option). The device provides maximum transport mobility and advantage of a seat electrically for a Person able to Can be raised that joy - Stick Controller. sperate the standard

    Device Description

    Powered wheelchair

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a power wheelchair, Mobilife Model (Mobil Raizer 22). This document focuses on the regulatory clearance process for a medical device and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

    Therefore, I cannot answer your request based on the provided text. The questions you've asked (about sample sizes, ground truth, expert qualifications, MRMC studies, etc.) are relevant to the evaluation of AI/ML software as a medical device, which is not what this document describes.

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