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510(k) Data Aggregation

    K Number
    K181849
    Device Name
    iStim S2 OTC Pain Relief TENS
    Date Cleared
    2018-08-10

    (30 days)

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

    Everyway Medical Instruments CO., LDT.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    iStim S2 OTC Pain Relief TENS is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
    Device Description
    Not Found
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    K Number
    K181207
    Device Name
    Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
    Date Cleared
    2018-06-06

    (30 days)

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

    Everyway Medical Instruments CO., LDT.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
    Device Description
    The Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) is a dual channel transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the user's skin. The output and waveform characteristic are fixed for every operation mode, only the intensity is adjustable within specified limit. The Balego™ TENS Digital Edition consists mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the user's skin so as to transmit this stimulus current for pain relief. The stimulation modes for Balego™ TENS Digital Edition are pre-program modes with fixed pulse width, pulse rate, frequency. The amplitude for each program are adjustable. The subject and predicate devices both use Everyway Electrode, Wire Series/ model no. KF5050, size 50x50mm, wire type as a standard accessory. The Electrode was cleared under K083302. With the combination of the main device parts, the device can be placed on the treatment locations as recommended in the user manual for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
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