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510(k) Data Aggregation

    K Number
    K121578
    Device Name
    ATOM 1 (MODEL: BRC 2200)
    Date Cleared
    2012-07-31

    (62 days)

    Product Code
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOELECTRIC RESEARCH CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BRC 2200 is intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
    Device Description
    The BRC 2200 is a non-invasive, therapeutic device that delivers bipolar electrical current. In order to maintain a neutral charge for each cycle, the device delivers a current of one polarity for the first half of the cycle and then the opposite polarity for the second half of the cycle. The BRC 2200 is a hand-held device with a touch screen designed for ease of the user. The licensed healthcare professional uses a pass code to access screens regarding the treatment options and patient information. The main treatment screen shows the progression of the treatment, date, time, battery level, and gives options to pause the treatment or reduce the power if the patient feels discomfort. The BRC 2200 contains 24 pre-programmed treatments accessible only to the licensed healthcare professional. Using the designated pass code, the licensed healthcare professional selects the treatment and updates the correct patient information to the device before starting the treatment. Once the treatment has started, the patient will be able to pause the treatment or reduce power if he/she feels mild discomfort. Components included with the BRC 2200 contain a pair of single-use electrodes, a pair of electrode cables, a battery charger, and an optional USB cable. The electrodes come in a variety of sizes ranging from extra-small to large and either two inch or three inch widths. The electrodes attach by being circumferentially wrapped around a limb or the trunk of the body and the overlapping ends secured with hook and loop fasteners to maintain circumferential tension during treatment. The electrodes consist of a conductive layer sandwiched between a layer of polyurethane foam and a layer of synthetic neoprene. The foam is in contact with normal, intact skin for up to 3 hours and complies with ISO 10993. The electrode cables attach to the electrodes via a silver metal hook and loop fastener which then attaches to the BRC 2200 using push-pull connectors. The electrode cables used with the electrodes can be multi-use and are available in 40, 50, and 60 inches in length. These three different sizes in electrode cables allow for differences in the placement of electrodes and the different sizes of patients. In order to conduct the current through the body, the electrodes require water as the conducting medium. This is achieved by soaking the electrodes in water or normal saline solution and applying to the location in which current flow should be directed. The BRC 2200 is powered by a Tenergy 3.7V Li-polymer rechargeable battery. The battery is charged by the Tenergy 3.7V Li-ion battery charger model OH-1048A0451500U. The optional USB cable allows the licensed healthcare professional to obtain treatment information and transfer it to a computer. The BRC 2200 is a prescription device and can be used in a healthcare facility or at home.
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