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510(k) Data Aggregation

    K Number
    K200931
    Device Name
    RF Surgical Generator
    Manufacturer
    Date Cleared
    2020-11-24

    (231 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fulwell LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    RF Surgical Generator FW-120A is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.
    Device Description
    RF Surgical Generator FW-120A, is a compact source of high power RF energy, enhanced capability of radiosurgery generator, which can be employed for a variety of radiosurgery procedures, such as cut and coagulate living human tissue. The device which is consisted of a generator, an IEC Neutral Plate, and a Two Pedal Footswitch, provides 5 modes and corresponding output power ranges that is user/operator selectable based on the surgical procedure undertaken. The action is achieved by front panel selection of waveforms and power level. All selection is affected through push buttons and indicators which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays The device is provided with safety features of automatically system initialize self-check after power on and continuously monitored during the device running. The device will provide error information and/ or alerts when detect following faults, such as a) Accessary fail connection, b) Overheating of Main Unit, c) Neutral plates Contact resistance exceed the limit, d) System initialize error. The error monitoring is interlocked with the controls to prevent operation when fault condition happened in the unit. The generator is configured for Monopolar and Biopolar output and the final output power could be controlled by pedal foot switch and/or hand switches. Recommended Monopolar Handpieces 510(k) No.: K092634. Recommended IEC Neutral Plate 510(k) No.: K102372.
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    K Number
    K183564
    Device Name
    Electrosurgical Generator
    Manufacturer
    Date Cleared
    2019-06-13

    (175 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fulwell LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electrosurgical Generator – Model FW-350A is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the surgical operation area.
    Device Description
    Electrosurgical Generator-Model FW-350A has Monopolar and Bipolar modes that can satisfy the general requirements of electrosurgical field. The CQMS function can monitor the area of patient body applied with ESU pad during the operation every 40ps. Once the pad loses or that area shrinks, the computer will cut off all outputs within 40us to prevent patient from getting burnt. The PPS system ensure the safety of a constant output that send out compulsory stimulation at the initial instant of every CUT or COAG to make the operation process go smoothly. Moreover, the memory function can decrease the medical staff workload and human errors. At last, the Power ON self diagnostics function can diagnosis whether all working modes and functions are working normally and feedback information by code displaying and alarm voice prompt that the operational safety is improved greatly.
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