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510(k) Data Aggregation

    K Number
    K132179
    Device Name
    ARASYS
    Manufacturer
    ION GENIUS INC
    Date Cleared
    2014-04-28

    (287 days)

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

    ION GENIUS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Arasys Genius is intended for muscle conditioning to stimulate healthy muscles. The Arasys Genius is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the Arasys Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Arasys Genius is only offered under prescription given by a physician licensed in the state in which he or she practices. The Arasys Genius is intended to be operated by a trained professional who is always present to monitor treatment.
    Device Description
    The Arasys Genius has the exact same technological characteristics, the same number of channels and the exact same frequencies as the predicate. Arasys Genius is made by UV Innovations by the same engineers and technicians that make the lon Magnum Genius K12315B. Arasys Genius has the exact same technology of the predicate, lon Magnum Genius K123158 with the exceptions. The Arasys Genius is a muscle stimulator with six ports just like the predicate and one output that is the same for all ports just like the predicate. The unit is designed for healthy men & women to provide muscle conditioning. Arasys Genius stimulator provides selections of different programs through manual adjustment of the three different frequencies of the device, 90 Hz, 100 Hz, in an identical fashion as the predicate. The Arasys Genius maximum output current is 100 ma which is equivalent to the maximum output current of the predicate. The Arasys has a maximum output voltage of 200 volts which is equivalent to the maximum output voltage of the predicate. An LCD display shows the balance treatment time in the same fashion as it happens with the predicate. The output signal is biphasic, rectangular and based on a voltage and current regulated technology as it does in the predicate. The unit is easy and simple to use. The Arasys has an identical indication for use just like the predicate as it is intended for muscle conditioning to stimulate healthy muscles. The Aras is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the Arasys Genius programs is designed for ailing muscles and its use on such muscles is contraindicated. The Arasys Genius is only offered under prescription given by a physioian licensed in the state in which he or she practices.
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    K Number
    K123158
    Device Name
    ION MAGNUM GENIUS
    Manufacturer
    ION GENIUS INC
    Date Cleared
    2013-06-21

    (255 days)

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

    ION GENIUS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ion Magnum Genius is intended for muscle conditioning to stimulate healthy muscles. The Ion Magnum Genius is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Ion Magnum Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Ion Magnum Genius is only offered under prescription given by a physician licensed in the state in which he or she practices.
    Device Description
    Ion Magnum Genius is a muscle stimulator with six ports and one output that is the same for all ports. The unit is designed for healthy men & women to provide muscle conditioning. Ion Magnum Genius stimulator provides selections of different programs through manual adjustment of the three different frequencies of the device, 90 Hz, 100 Hz which are within the same range as the predicate that offer a range from 1-120 Hz. The setting that the frequency button is turned shows which frequency the device is set on. The device delivers a voltage of 50 volts at 500 Ohms load and 100ma just like the predicate. It delivers a voltage of 200 volts at 10K Ohms just like the predicate. The Ion Magnum maximum output current is 100 ma which is equivalent to the maximum output current of the predicate. The Ion Magnum has a maximum output current of 200 volts which is equivalent to the maximum output current of the predicate. The device primarily treats abdominal muscles (ABS). LCD shows the balance treatment time. The output signal is biphasic, rectangular and based on a voltage and current regulated technology. The unit is easy and simple to use. Ion Magnum is suitable for use by all healthy adults. However as with other muscle stimulators some care is needed when using the Ion Magnum Genius [see contraindications and warnings in manual]
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