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510(k) Data Aggregation

    K Number
    K210727
    Device Name
    HotDog Warming Mattress + Return Electrode
    Manufacturer
    Augustine Temperature Management LLC
    Date Cleared
    2022-02-01

    (327 days)

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

    Augustine Temperature Management LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HotDog Return Electrode Mattress is intended to conduct monopolar electrosurgical energy from the target tissue of a patient back to one electrosurgical unit (ESU) or generator in monopolar surgery. The HotDog Return Electrode Mattress is restricted to use with isolated monopolar electrosurgical generators. The Hotdog Return Electrode Mattress is intended for use with adult patients only.
    Device Description
    The HotDog Return Electrode Mattress is sold with a Return Electrode Cable, 4m (A136) that enables connection to one electrosurgical generator. The HotDog Return Electrode Mattress completes the circuit required for electrosurgery through Capacitive method. A capacitor is created when two conductive plates are separated by an insulator. The separation of two conductive plates by an insulator creates a capacitor. The insulator prevents current from flowing directly between the two plates, thereby avoiding the resistance which creates heat. With capacitive grounding, current from the active electrode produces a charge on the first conductive plate. This causes an equal (but opposite) charge to form on the second conductive plate. Current produced by the charge on the second plate produces electrical returns to the generator and completes the circuit.
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