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

    COMPRESSIBLE LIMB SLEEVE SYSTEM

    K Number: K130385 · Decision Feb 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    3
    Review Days
    368

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    Basic Information

    Device Name
    COMPRESSIBLE LIMB SLEEVE SYSTEM
    K Number
    K130385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Maxstar Industrial Co., Ltd.
    Date Received
    February 15, 2013
    Decision Date
    February 18, 2014
    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 Maxstar Industrial Co., Ltd.

    K Number Device Name
    K191441 Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)
    K173158 Air Relax