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

    MEDS-3 NEUROMUSCULAR STIMULATOR

    K Number: K023443 · Decision Jan 13, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    MEDS-3 NEUROMUSCULAR STIMULATOR
    K Number
    K023443
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Equipment Device Specialists
    Date Received
    October 15, 2002
    Decision Date
    January 13, 2003
    Product Code
    GZJ
    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
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

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    Other Clearances by Medical Equipment Device Specialists

    K Number Device Name
    K040193 MODEL GST-1
    K032055 MEDS-4-INF+
    K023435 MEDS-4 NEUROMUSCULAR STIMULATOR
    K023446 MEDS-3 NEUROMUSCULAR STIMULATOR
    K023439 MEDS-4 NEUROMUSCULAR STIMULATOR