BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    ACTIVECARE ++ SYSTEM

    K Number: K060146 · Decision Mar 8, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    10
    Review Days
    48

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    Basic Information

    Device Name
    ACTIVECARE ++ SYSTEM
    K Number
    K060146
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Compression Systems (Dbn) , Ltd.
    Date Received
    January 19, 2006
    Decision Date
    March 8, 2006
    Product Code
    JOW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOW Sleeve, Limb, Compressible

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    Other Clearances by Medical Compression Systems (Dbn) , Ltd.

    K Number Device Name
    K160431 ActiveCare Home
    K140755 ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS
    K113525 ACTIVECARE DVT ACTIVECARE+SFT
    K110159 ACTIVECARE SFT
    K023573 WIZAIR COMPRESSION SYSTEM
    K012994 WIZAIR DVT
    K002287 WIZAIR COMPRESSION SYSTEM
    K993758 PROAIR 3000 COMPRESSION SYSTEM
    K994057 SLENDAIR 4000 COMPRESSION SYSTEM