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510(k) Data Aggregation

    K Number
    K243572
    Device Name
    Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La
    Manufacturer
    Avanos Medical, Inc.
    Date Cleared
    2025-01-31

    (74 days)

    Product Code
    IRP,ILO
    Regulation Number
    890.5650
    Type
    Special
    Panel
    Physical Medicine (PM)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap -

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

    The Game Ready system is indicated for the temporary relief of minor muscle aches and pains. The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulate kneading and stroking of tissues using an inflatable wrap. The Game Ready system is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.

    Device Description

    Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, Large, Right (590432-04); Game Ready Shoulder Wrap, Medium, Left (590424-04); Game Ready Shoulder Wrap, Large, Left (590434-04); Game Ready Hip/Groin Wrap, Right (590602-04); Game Ready Hip/Groin Wrap, Left (590604-04); Game Ready Straight Knee Wrap (590100-04); Game Articulated Knee Wrap (590160-04); Game Ready Ankle Wrap, Large (590330-04); Game Ready Ankle Wrap, Extra Large (590340-04)

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the Game Ready System, a powered inflatable tube massager. It does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions of the Act. It outlines regulatory requirements for the manufacturer but does not include details on performance assessment studies or acceptance criteria that would typically be found in a clinical or validation study report.

    Therefore, I cannot extract the requested information from the provided input.

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