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510(k) Data Aggregation

    K Number
    K970590
    Device Name
    N/A
    Manufacturer
    NORTH AMERICAN TECHNICAL SERVICES CORP.
    Date Cleared
    1997-06-13

    (115 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K970590,K970592
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    NotFound

    Device Description

    Health Zone/Healthy Vibes Mini Rechargeable Infrared Massager, Model KM-213H; Health Zone/Healthy Vibes Infrared Massager Set, Model KM-201

    AI/ML Overview

    This FDA 510(k) letter for the Health Zone/Healthy Vibes Mini Rechargeable Infrared Massager and Infrared Massager Set (models KM-213H and KM-201, respectively) does not contain the information requested about acceptance criteria or a study proving the device meets said criteria.

    The letter is primarily a declaration of substantial equivalence to previously marketed predicate devices, which allows the manufacturer to market the new devices. It confirms that the devices are regulatory Class II and are subject to general controls.

    Therefore, I cannot provide the detailed information requested in the prompt based on this document. The document primarily focuses on regulatory approval based on equivalence, not on specific performance metrics or studies.

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