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

    RT300 FES cycle ergometer

    K Number: K162470 · Decision Jul 11, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    60
    Applicant Total
    10
    Review Days
    308

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    Basic Information

    Device Name
    RT300 FES cycle ergometer
    K Number
    K162470
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5810
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Restorative Therapies, Inc.
    Date Received
    September 6, 2016
    Decision Date
    July 11, 2017
    Product Code
    GZI
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GZI Stimulator, Neuromuscular, External Functional

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    Other Clearances by Restorative Therapies, Inc.

    K Number Device Name
    K160614 Xcite Clinical Station
    K103370 RT200
    K103366 RT600
    K090750 RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581
    K072398 RT300-S AND RT300-SP FES CYCLE ERGOMETER
    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