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

    INTERMITTENT COMPRESSOR SYSTEM

    K Number: K964957 · Decision Feb 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    2
    Review Days
    75

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    Basic Information

    Device Name
    INTERMITTENT COMPRESSOR SYSTEM
    K Number
    K964957
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eischoco, Inc.
    Date Received
    December 11, 1996
    Decision Date
    February 24, 1997
    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 Eischoco, Inc.

    K Number Device Name
    K991921 INTERMITTENT COMPRESSION BOOT FOR OTC