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

    HANDMASTER

    K Number: K031900 · Decision Aug 8, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    60
    Applicant Total
    7
    Review Days
    50

    Basic Information

    Device Name
    HANDMASTER
    K Number
    K031900
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5810
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
    Date Received
    June 19, 2003
    Decision Date
    August 8, 2003
    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 NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS

    K Number Device Name
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    K080219 MODIFICATION TO:NESS L300
    K053468 NESS L300
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    K012823 MODIFICATION TO HANDMASTER