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

    5000Z FIREFLY SYSTEM

    K Number: K133502 · Decision Dec 3, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    8
    Review Days
    384

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    Basic Information

    Device Name
    5000Z FIREFLY SYSTEM
    K Number
    K133502
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prizm Medical, Inc.
    Date Received
    November 14, 2013
    Decision Date
    December 3, 2014
    Product Code
    NUH
    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
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

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    Other Clearances by Prizm Medical, Inc.

    K Number Device Name
    K033122 5000Z SYSTEM (OTC)
    K032239 THERA-CREAM, MODEL TCT004
    K024181 PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM
    K012974 PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007
    K951727 Z-WATCH SYSTEM
    K944487 ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES
    K932299 ELECTRO-MESH