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

    Xcite Clinical Station

    K Number: K160614 · Decision Dec 16, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    10
    Review Days
    288

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    Basic Information

    Device Name
    Xcite Clinical Station
    K Number
    K160614
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Restorative Therapies, Inc.
    Date Received
    March 3, 2016
    Decision Date
    December 16, 2016
    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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    K071486 RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053
    K071113 RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053
    K060032 RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053
    K050036 FES CYCLE ERGOMETER, MODEL RT300-S