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510(k) Data Aggregation

    K Number
    K990866
    Device Name
    QUINTON MEDTRACK CR PLUS TREADMILL
    Manufacturer
    QUINTON, INC.
    Date Cleared
    1999-04-29

    (44 days)

    Product Code
    ISD
    Regulation Number
    890.5360
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUINTON MEDTRACK CR PLUS TREADMILL

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

    The Quinton MedTrack CR Plus Treadmill is intended to be used as a rehabilitation device for cardiovascular conditioning. The intended population are ambulatory patients undergoing exercise rehabilitation.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a treadmill (Quinton MedTrack CR Plus Treadmill). This type of document declares substantial equivalence to a predicate device but does not contain any information regarding acceptance criteria or a study proving device performance against such criteria.

    Therefore, I cannot extract the requested information from this document. The document primarily focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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