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510(k) Data Aggregation

    K Number
    K050595
    Device Name
    FT2000 SEQUENCER FOR MUSCLE STIMULATOR
    Date Cleared
    2005-05-23

    (76 days)

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

    MIDWEST DEVELOPMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    When used in combination with a listed stimulator, such as the NT2000 manufactured by Bio-Medical Research Ltd., the Midwest Development FT2000 Sequencer provides electrical neuromuscular stimulation for the purposes of relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, or to maintain or increase range of motion. Sequencing provided by the FT2000 directs the stimulator signal from the stimulator device to selected patient electrode sites without modifying the original signal characteristics. The FT2000 permits treatment in user selected time sequences of up to 24 pairs of electrodes by having 12 pairs on each side of the body. The C12000 Software allows the user to set treatment times for each electrode pair. The FT2000 is a prescription device.
    Device Description
    A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for programmable timed channel selection, patient cable, and electrodes applied to the skin. Various types of time-variable waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced systems may have more than one output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence. The FT2000 is a sequencing device only - it does not generate stimulation signals, but directs the signals from the stimulator to the patient, applying a physician prescribed sequence to the treatment. Sequenced treatment has several advantages, including patient convenience and controlled treatment of specific sites. The FT2000 Sequencer is designed to mechanically and electrically mate with the NT2000, manufactured by Bio-Medical Research, Ltd., a 510(k) listed device which provides muscle stimulation signals. The FT2000 embodies similar technological characteristics as the predicate devices. Both devices employ embedded microcontrollers to store and provide treatment profiles to the user. Both have a means for the patient to easily control or suspend treatment. Both devices are battery operated to ensure that treatment is isolated. As stated in (4), the FT2000 is a sequencing device only - it does not generate stimulation signals, but directs the signals from the stimulator to the patient via a bank of relays per a prescribed treatment profile. The CI2000 PC software allows the physician to set up a treatment profile for the patient and store it in the FT2000. Treatment profiles cannot be modified by the patient.
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