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510(k) Data Aggregation

    K Number
    K020427
    Device Name
    AB BELT
    Manufacturer
    THE DEZAC GROUP
    Date Cleared
    2002-09-13

    (217 days)

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

    THE DEZAC GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ab Belt device is indicated for use for the improvement of abdominal muscle tone, for strengthening of the abdominal muscles and for developing a firmer abdomen.
    Device Description
    The Ab Belt is a single channel battery operated muscle stimulation system specifically designed for improving abdominal muscle tone, for strengthening the abdominal muscles and for developing a firmer abdomen. It comprises an electronic stimulation controller module which generates the required electrical stimulation signals and an abdominally worn electrode belt which connects the signals from the stimulator to the skin electrodes located on the inner surface of the belt. The device is supplied with a set of three identical electrodes, a tube of conductive gel, an instruction manual, a set of batteries and a fabric belt extension for fuller figures. Power is derived from three (3) 1.5V AAA batteries located on an external pop-on connector and slid into a pocket on the belt facia. The central umbilical electrode is common to each of the left and right stimulation circuits. The electrodes connect mechanically to 'press-studs' mounted on the inner face of the abdominal belt. The studs are presented in such a way that each of the outer electrodes may be rotated about a single common stud to accommodate both inner and outer muscle groups. Only these single common studs of the outer electrodes and the central umbilical electrode are electrically connected to the stimulator unit. This prevents stimulation to the user through a stud, which is not covered by an electrode pad. The user extends the belt and puts it in a wrapping motion from front to back, closing it at the back using Velcro patches. When the belt is in place the central electrode locates over the umbilicus and the two outer electrodes locate on either side of the body towards the mid axillary line, between the pelvis and the rib cage. It is well known in the art that this electrode positioning is particularly useful for stimulating the abdominal muscles. The pulsed stimulation current passes between the outer and center electrodes only. There is no current passed from outer electrode to outer electrode. The user has no access to the wiring or connectors as they are stored internally within the belt structure. As a result he or she cannot alter the current path and so the possibilities for misuse are greatly reduced.
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    K Number
    K020429
    Device Name
    AB BELT PRO
    Manufacturer
    THE DEZAC GROUP
    Date Cleared
    2002-09-13

    (217 days)

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

    THE DEZAC GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ab Belt Pro device is indicated for use for the improvement of abdominal muscle tone, for strengthening of the abdominal muscles and for developing a firmer abdomen.
    Device Description
    The Ab Belt Pro is a single channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles for the purposes of improving abdominal muscle tone, strengthening the abdominal muscles and developing a firmer abdomen. It comprises an electronic stimulation controller module which generates the required electrical stimulation signals and an abdominally worn electrode belt which connects the signals from the stimulator to the skin electrodes located on the inner surface of the belt.
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    K Number
    K022006
    Device Name
    CONDUCTIVE GEL
    Manufacturer
    THE DEZAC GROUP
    Date Cleared
    2002-09-13

    (86 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE DEZAC GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulators) and EMS (electrical muscle stimulators). The Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.
    Device Description
    The Conductive Gel is a colored gel used for reducing the impedance between electrodes and the skin. The gel is to be generously applied to the area under an electrode, which is to be used. The gel can be washed off the skin after use.
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