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

    BIOMOVE 3000

    K Number: K042650 · Decision Jan 27, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    2
    Review Days
    121

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    Basic Information

    Device Name
    BIOMOVE 3000
    K Number
    K042650
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Curatronic, Ltd.
    Date Received
    September 28, 2004
    Decision Date
    January 27, 2005
    Product Code
    IPF
    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
    IPF Stimulator, Muscle, Powered

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    Other Clearances by Curatronic, Ltd.

    K Number Device Name
    K080787 BIOMOVE 5000 SYSTEM