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510(k) Data Aggregation

    K Number
    K030017
    Device Name
    CHUMP
    Manufacturer
    COLOURS 'N MOTION
    Date Cleared
    2003-05-01

    (119 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CHUMP

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

    Not Found.

    Device Description

    Mechanical Wheelchair "CHUMP", "KRYPTO"

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a mechanical wheelchair. It explicitly states that the device is "substantially equivalent" to legally marketed predicate devices and is classified as Class I.

    The information provided does not describe an acceptance criteria and study for a device that uses AI or machine learning. It pertains to a physical product (a wheelchair) and its fire retardancy testing, which is a physical property test, not an AI performance study.

    Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, MRMC study, or standalone performance) because this document does not contain any information related to AI or machine learning performance.

    The only relevant "acceptance criteria" mentioned is the "Fire retardant test accomplished at Swedish Handicapped Institute to I.S.O. 7176 under umbrella of ISO 9000/9001" and "All fabric is in accordance to California specification 117." However, these are not AI-specific performance metrics.

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