BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ABLE-X

    K Number: K120783 · Decision Jun 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    264
    Registration Numbers
    264
    Same Product Code
    42
    Applicant Total
    1
    Review Days
    97

    Basic Information

    Device Name
    ABLE-X
    K Number
    K120783
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5370
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    IM-ABLE LTD
    Date Received
    March 15, 2012
    Decision Date
    June 20, 2012
    Product Code
    ION
    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
    ION Exerciser, Non-Measuring

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