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510(k) Data Aggregation

    K Number
    K241899
    Device Name
    Pelvic Floor Stimulator (Intrelief PFE)
    Manufacturer
    EasyMed Instruments Co., Ltd.
    Date Cleared
    2024-11-27

    (152 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    EasyMed Instruments Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intrelief PFE is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
    Device Description
    Not Found
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    K Number
    K211263
    Device Name
    Intrelief
    Manufacturer
    EasyMed Instruments Co., Ltd.
    Date Cleared
    2021-12-30

    (248 days)

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

    EasyMed Instruments Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intrelief provides transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS) device for the respective indications listed below. TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    Not Found
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    K Number
    K140168
    Device Name
    EASYSTIM TN28_OTC
    Manufacturer
    EASYMED INSTRUMENTS CO., LTD.
    Date Cleared
    2014-08-28

    (217 days)

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

    EASYMED INSTRUMENTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EasyStim TN28 OTC is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
    Device Description
    EasyStim TN28 OTC is a portable, battery powered T.E.N.S. device for pain relief intended for over-the-counter use. There are totally eight (8) modes that are intended for application to the following areas: Shoulder/ Arm, Lower Back and Leg/Foot. The accessories include electrode cable and electrodes pads which are placed on the specific body part. Generally, the electrodes are connected to the device through electrode cable. The device produces either a fixed or modulated electrical signal through electrodes normally placed on a patient's skin over the area of pain. Since the device is battery powered, there is no connection to AC mains supply.
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