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510(k) Data Aggregation

    K Number
    K081026
    Device Name
    BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5
    Manufacturer
    SPORT-ELEC S.A.
    Date Cleared
    2008-11-05

    (209 days)

    Product Code
    NGX
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPORT-ELEC S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Body Control is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles. It is indicated for use on the abdominal muscles. Contraindicated use on injured or otherwise impaired muscles Not intended for use in any therapy or for the treatment of any medical conditions or diseases
    Device Description
    Body Control is a 2 channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It is comprised of an electronic stimulator module which generates the required stimulation signals. Body Control is comprised of a belt with integral electrodes, which connects the signals from the stimulator to the skin. The built-in electrodes are located on the inner surface of the belts. The product is supplied with the cream VC 57B/53 -148, a User's Guide and a carry case.
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    K Number
    K061914
    Device Name
    SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS
    Manufacturer
    SPORT-ELEC S.A.
    Date Cleared
    2007-07-26

    (385 days)

    Product Code
    NGX
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPORT-ELEC S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CT5 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles and for the development of a firmer abdomen
    Device Description
    CT5 is a 2 channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It comprises namely an electronic stimulator module which generates the required stimulation signals. CT5 comprises belt with integral electrodes, which connects the signals from the stimulator to the skin. The built-in electrodes are located on the inner surface of the belt, which take the place of the lead wires. The product is supplied with the cream VC 57B/53 -148, a User's Guide and a carry case.
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