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510(k) Data Aggregation

    K Number
    K993600
    Device Name
    MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841
    Manufacturer
    NISHA COMMUNICATION INDUSTRIES
    Date Cleared
    2001-02-05

    (469 days)

    Product Code
    LIH
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    NISHA COMMUNICATION INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K980040
    Device Name
    ELECTRONIC MUSCLE STIMULATOR - MICROSTIM J-1304D
    Manufacturer
    NISHA COMMUNICATION INDUSTRIES
    Date Cleared
    1998-07-13

    (189 days)

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

    NISHA COMMUNICATION INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Microstim J 1304D is an Electrical Muscle Stimulator to be used by Physiotherapy or clinicians in Physical Medicine for following applications :- 1. Relaxation of Muscle Spasm. 2. Prevention or retardation of disuse atrophy. 3. Increase local body circulation. 4. Muscle re-education. 5. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis. 6. Maintaining or increasing range of motion.
    Device Description
    Microstim J-1304D is an electrotherapy unit used for electrical Muscle Stimulator This microprocessor based circuit generates biphasic square pulse, with enhanced accuracy and dependability. The pulse duration is preset to most effectively stimulate motor fibers. The waveforms are delivered in an envelope of trapezium shaped impulse. The stimulation is more effective yet being smooth and comfortable. J-1304D provides such treatment to four patients simultaneously. Each channel separately has power increase and start/stop key. The increase in intensity by touch button key on membrane panel gives very smooth rise. It delivers exact amount of current that can be visualized as % power in display window. There are four frequency parameters to choose from 200,300,600 and 800 Hz. The treatment time can be selected from 15,30,45 and 60 min.Cyclic 'off' time at 0 gives advantage of reaching the maximum tolerance level or desired level of intensity and then selection from 2 sec.4 sec. and 8 sec 'off' time for kind of treatment. The design of Microstim J-1304D, as having slanted front panel, is for the ease of use to the clinician. Made of aluminum it is strong and sturdy. The unit is supplied with lead wire, four electrode wires and four sets of self adhesive electrodes.
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