BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Revitive IX (OTC)

    K Number: K143207 · Decision Mar 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    161
    Applicant Total
    7
    Review Days
    136

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    Basic Information

    Device Name
    Revitive IX (OTC)
    K Number
    K143207
    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
    November 7, 2014
    Decision Date
    March 23, 2015
    Product Code
    NGX
    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
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning

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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
    K140772 AEROSURE MEDIC
    K123354 REVITIVE IX