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510(k) Data Aggregation

    K Number
    K073334
    Device Name
    OHMNISCAN NG
    Date Cleared
    2008-08-22

    (268 days)

    Product Code
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHRISTINE VALMY INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Ohmnsiscan NG is a non prescription device and is used on healthy subjects with no known disease or condition, and is identified as used for generally healthy adults (18-65). It is used to estimate the following: - Impedance(Z in ohms) . - Total body water (TBW in L and in %) . - Lean Mass(LM in KG) . - Fat Mass (FM in KG and %) . - Basal Metabolism(Kcal) . - Daily energy needs(Kcal) ● - B.M.I. (Body Mass Index). .
    Device Description
    Ohmniscan NG is a high performance portable bioimpedance measuring device that enables evaluation of daily energy needs, fat mass (in % of total weight and in kg), lean mass (in kg) hydric condition (in % of total weight and in kg), body mass index, using a painless micro current technique. It is used for the initial assessment and for treatment monitoring. Regular check allows fat loss to be monitored and the results are used as a highly motivational tool. Ohmniscan NG releases a very low intensity alternating current at a 50 KHz frequency, by applying the four polar methods to measure the body resistance. This measurement determines the client's impedance. Ohmniscan NG enables the creation of 100 customer cards with upto 8 measurements of the customer, their records, the interpretations, and the comparison between 2 measurements of the same client. It enables the creation of a customer file with surname, first name, sex, race, age, height, weight, activity, date of measurement, interpretation, and comparisons. Its fast measuring function allows calculations to be made in a minimum amount of time and they can be interpreted later. The unit comes complete with pen, connection wires and electrodes. The device is delivered with printer for ticket results.
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