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510(k) Data Aggregation

    K Number
    K102014
    Device Name
    TENS STIMULATOR, MODELS 2800 AND 3000
    Manufacturer
    KOALATY PRODUCTS, INC.
    Date Cleared
    2010-08-31

    (46 days)

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

    KOALATY PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
    Device Description
    TENS Series Electro-Stimulator, which includes models TENS 2800 and TENS 3000, are Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves through the cable and electrode placed on the skin. The parameters of units are controlled by the rotate buttons. Its intensity level is adjustable according to the needs of patients. These TENS electro-stimulator have the same housing in a molded portable plastic case, an accessible, switch, and accessible battery storage compartment. The case shape is rectangular, The process to set the parameter and attach lead wires to the two models is also the same except the Housing printing artwork, Mode No. TENS 3000 stimulator has three treatment mode: normal mode, burst mode and modulation mode. The treatment mode can by selected by switch. TENS 2800 only one treatment mode: normal mode. The difference on the two device can be identified by panel, Mode No.
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    K Number
    K080661
    Device Name
    MODELS TENS 7000, EMS 7500 AND TWIN STIM
    Manufacturer
    KOALATY PRODUCTS, INC.
    Date Cleared
    2008-03-24

    (14 days)

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

    KOALATY PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    APPLICABLE FOR TENS 7000 AND TWIN STIM: 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 main and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems APPLICABLE FOR EMS 7500 and TWIN STIM: 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 ouscle 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
    This series, which includes models TENS 7000, EMS 7500, and TWIN STIM, are Transcutaneous Electrical Nerve Stimulator for pain relief and/or Electrical Muscle Stimulator. The 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 have the same housing. The process to set the parameter and attach lead wires to the unit are also the same. Yet, they have different liquid crystal display and parameters for patients to create their own settings. The TENS 7000 is a TENS device with 5 modes and adjustable pulse rate, pulse width and timer. The EMS 7500 is an EMS device with 3 modes and adjustable pulse rate, pulse width, contraction time, relaxation time, ramp time and timer. The TWIN STIM is a 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 TENS 7000 and EMS 7500. The difference on the three units can be identified by the liquid crystal display.
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    K Number
    K072795
    Device Name
    MODELS EMS 5.0, EMS 5.1
    Manufacturer
    KOALATY PRODUCTS, INC.
    Date Cleared
    2007-11-27

    (57 days)

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

    KOALATY PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrical Muscle Stimulator Series (Model Numbers EMS 5.0, EMS 5.1) is an electrically powered muscle stimulator intended 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: - Relaxing muscle spasms - Increasing local blood circulation. - -Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. - Muscle re-education. - Maintaining or increasing range of motion - Preventing or retarding disuse atrophy
    Device Description
    EMS is a battery operated pulse generator that sends electrical impulses through electrodes to the body and reaches the underlying or muscle group. Both EMS 5.0 and EMS 5.1 are analogue units with dual channel. EMS 5.0 has a selectable pulse rate of 5, 30 and 100 Hz, while EMS 5.1 has an adjustable pulse rate of 2 to 150 Hz.
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