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510(k) Data Aggregation

    K Number
    K213116
    Device Name
    Everyway Incontinence Stimulation System
    Manufacturer
    Everyway Medical Instruments Co., Ltd.
    Date Cleared
    2021-12-03

    (67 days)

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

    Everyway Medical Instruments Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Everyway Incontinence Stimulation System 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
    Everyway Incontinence Stimulation System ( Stimulator models EM-2400 and EM-5300 with Vaginal Probe models PR-02A, PR-04A and PR-14A )
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    K Number
    K202470
    Device Name
    Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300
    Manufacturer
    Everyway Medical Instruments Co., Ltd.
    Date Cleared
    2020-11-25

    (89 days)

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

    Everyway Medical Instruments Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS (For model EM-6000, EM-6100 & EM-6300) : 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. (Choose TENS B/N/M/S1/S2 adjustable mode & TENS Modes P to P6 for EM-6300). EMS (For model EM-6000, EM-6200 & EM-6300): intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (Choose EMS C/S/A adjustable mode & EMS Modes P7 to P12 for EM-6300).
    Device Description
    Not Found
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    K Number
    K202317
    Device Name
    Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806
    Manufacturer
    Everyway Medical Instruments Co., Ltd.
    Date Cleared
    2020-11-13

    (88 days)

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

    Everyway Medical Instruments Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS: 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. (For EV-806: Choose TENS Modes B/N/M/SD1/SD2 adjustable mode). EMS: intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (For EV-806 : Choose EMS Modes C/S/A adjustable mode)
    Device Description
    Not Found
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    K Number
    K192589
    Device Name
    Everyway OTC TENS/EMS Combination
    Manufacturer
    EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
    Date Cleared
    2019-12-19

    (90 days)

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

    EVERYWAY MEDICAL INSTRUMENTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS: 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. (Choose TENS Modes B/N/M/SD1/SD2 as adjustable mode and P1 to P12 preset programs only for EV-906A). EMS: intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes C/S/A as adjustable mode and P13 to P24 preset programs only for EV-906A).
    Device Description
    Not Found
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    K Number
    K182753
    Device Name
    A6 OTC Pain Relief TENS
    Manufacturer
    Everyway Medical Instruments Co., Ltd.
    Date Cleared
    2018-10-26

    (28 days)

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

    Everyway Medical Instruments Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A6 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
    K182767
    Device Name
    V2 OTC Pain Relief TENS
    Manufacturer
    Everyway Medical Instruments Co., Ltd.
    Date Cleared
    2018-10-26

    (28 days)

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

    Everyway Medical Instruments Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    V2 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
    K181707
    Device Name
    Everyway Wireless TENS & EMS Unit
    Manufacturer
    Everyway Medical Instruments Co., Ltd.
    Date Cleared
    2018-09-26

    (90 days)

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

    Everyway Medical Instruments Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS: 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. EMS: intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that the EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance. The EMS may therefore be considered a technique of muscle training.
    Device Description
    Not Found
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    K Number
    K172919
    Device Name
    EV-804 OTC Pain Relief TENS
    Manufacturer
    Everyway Medical Instruments Co., Ltd.
    Date Cleared
    2018-04-19

    (206 days)

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

    Everyway Medical Instruments Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OTC Pain Relief TENS, model EV-804, 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
    K173186
    Device Name
    S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D
    Manufacturer
    Everyway Medical Instruments Co., Ltd.
    Date Cleared
    2018-02-28

    (149 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    Everyway Medical Instruments Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The S Series Electrodes (including S5105, S80120, SG4040, SG4368, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D) are intended for use with transcutaneous neurostimulation devices as over the counter. Some common type of neurostimulation devices include, but are not limited to, TENS devices. Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a patient's skin and a neurostimulation device.
    Device Description
    Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a patient's skin and a neurostimulation device.
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    K Number
    K151479
    Device Name
    EV-820 OTC Pain Relief TENS
    Manufacturer
    EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
    Date Cleared
    2015-10-16

    (136 days)

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

    EVERYWAY MEDICAL INSTRUMENTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Everyway EV-820 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
    The Everyway EV-820 OTC Pain Relief TENS 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 is fixed for every operation mode, only the intensity is adjustable within specified limit. The Everyway EV-820 OTC Pain Relief TENS 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 Everyway EV-820 OTC Pain Relief TENS is pre-program modes with fixed pulse width, pulse rate, frequency. The timer and amplitude for each program are adjustable. This operation way is considered the simple design change from the pre-program modes of comparison clear model, existing 510(k) cleared devices, Low Back Pain Relief System/ Model EV-820(K110716). Every operation mode of Everyway EV-820 OTC Pain Relief TENS Syste has its individual stimulation operation cycle.
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