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

    REVITIVE IX

    K Number: K123354 · Decision Jun 28, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    7
    Review Days
    240

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    Basic Information

    Device Name
    REVITIVE IX
    K Number
    K123354
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Actegy , Ltd.
    Date Received
    October 31, 2012
    Decision Date
    June 28, 2013
    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 Actegy , Ltd.

    K Number Device Name
    K210825 Revitive Medic Coach (Model Number 5575AQ)
    K192887 Revitive Medic Plus, Revitive Advanced 2
    K190924 Revitive Medic Plus, Revitive Advanced 2
    K152480 Revitive Medic; Revitive MV; Revitive LV
    K143207 Revitive IX (OTC)
    K140772 AEROSURE MEDIC