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

    ReWalk(TM)

    K Number: K160987 · Decision Jul 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    105

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    Basic Information

    Device Name
    ReWalk(TM)
    K Number
    K160987
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.3480
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rewalk Robotics, Inc.
    Date Received
    April 8, 2016
    Decision Date
    July 22, 2016
    Product Code
    PHL
    Advisory Committee
    Physical Medicine
    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
    PHL Powered Exoskeleton

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