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510(k) Data Aggregation

    K Number
    K082514
    Device Name
    TENS/EMS COMBO, EMS, TENS
    Manufacturer
    MEDIHIGHTEC MEDICAL CO., LTD.
    Date Cleared
    2008-10-21

    (49 days)

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

    MEDIHIGHTEC MEDICAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    APPLICABLE FOR MH8000 (TENS/EMS COMBINATION UNIT) AND MH6000 (TENS/EMS COMBINATION UNIT) AND MH8200 (TENS) AND MH6200 (TENS): This device is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for (1) Symptomatic relief and management of chronic (long term) intractable pain and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems. APPLICABLE FOR MH8000 (TENS/EMS COMBINATION UNIT) AND MH6000 (TENS/EMS COMBINATION UNIT) AND MH8100 (EMS) AND MH6100 (EMS): This device is an electrically powered muscle stimulator indicated for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy.
    Device Description
    The MH8000 Series, which includes models MH8000, MH8100, MH8200, MH6000, MH6100, MH6200, are Transcutaneous Electrical Nerve Stimulator for pain relief and/or Electrical Muscle Stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients. The three models MH8000, MH8100 and MH8200 have the same housing. The three models MH6000, MH6100 and MH6200 have the same housing. The process to set the parameter and attach lead wires to the six models are also the same. Yet, they have different liquid crystal display and parameters for patients to create their own settings. The MH8200 and MH6200 are the TENS device with 5 modes and adjustable pulse rate, pulse width and timer. The MH8100 and MH6100 are the EMS device with 3 modes and adjustable pulse rate, pulse width, on time, off time, ramp time and timer, The MH8000 and MH6000 are the combination unit with both TENS and EMS functions, The function can be selected by press buttons. The range of settings are identical to those of MH8200, MH8100, MH6100 and MH6200. The difference on the six units can be identified by the liquid crystal display.
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