BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    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

    K Number: K243572 · Decision Jan 31, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    8
    Review Days
    74

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    Basic Information

    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
    K Number
    K243572
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Avanos Medical, Inc.
    Date Received
    November 18, 2024
    Decision Date
    January 31, 2025
    Product Code
    IRP
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IRP Massager, Powered Inflatable Tube

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    Other Clearances by Avanos Medical, Inc.

    K Number Device Name
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    K203066 COOLIEF Cooled Radiofrequency Kit Advanced
    K192491 Coolief Radiofrequency Generator (CRG) System
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