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510(k) Data Aggregation

    K Number
    K153045
    Device Name
    SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator
    Manufacturer
    EASYMED INSTRUMENT CO., LTD.
    Date Cleared
    2016-05-13

    (207 days)

    Product Code
    BXN
    Regulation Number
    868.2775
    Why did this record match?
    Applicant Name (Manufacturer) :

    EASYMED INSTRUMENT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SunStim Peripheral Nerve Stimulator and SunStim Plus Peripheral Nerve Stimulator are a battery-powered device intended for monitoring the magnitude of neuromuscular block in general anesthesia, by delivering an electrical stimulus near a peripheral motor nerve.
    Device Description
    SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator are battery powered peripheral nerve stimulators which provide low electrical direct current (DC) stimulation in order to determine the level of anesthetic nerve block. The Stimulus Amplitude control dial provides variable current control (0 to 70 mA into a 2K ohm load). The Output Stimulus Pulse Indicator flashes each time current passes through the patient. Functions include: Double Burst (DBS), Train-of-Four, Twitch, and 100Hz Tetanus. The device offers sufficient output to ensure supramaximal stimulation: from 0 to 70 mA. SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator models have the same functions with the following exceptions: the SunStim™ Peripheral Nerve Stimulator functions do not include Double Burst and the 50 Hz Tetanus option.
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    K Number
    K143430
    Device Name
    SmartTENS
    Manufacturer
    EASYMED INSTRUMENT CO., LTD.
    Date Cleared
    2015-05-29

    (179 days)

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

    EASYMED INSTRUMENT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device 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
    SmartTENS is a portable battery powered T.E.N.S. device with a wireless remote control feature for over-the-counter use, mainly operating in home, clinic, or hospital environments. There are three control buttons on the unit itself: ON/OFF, intensity UP and intensity DOWM. The device is also designed to be controlled wirelessly through Bluetooth 4.0 connection (Frequency: 2402.0 - 2480.0 MHz) by a matched smart phone, which is featuring a mobile application (App) developed by EasyMed Instruments Co., Ltd. A user entered 6-digit security code ensures the access to the device can only be the user's matched smart phone, thus avoiding unauthorized controls to the device. There are totally seven (7) modes that are intended for pain relieving treatments to the following areas: Shoulder/ Arm, Lower Back and Leg/Foot. The specifications of each mode will be described in greater details in the User Manual.
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    K Number
    K050921
    Device Name
    EASYSTIM NMS-28
    Manufacturer
    EASYMED INSTRUMENT CO., LTD.
    Date Cleared
    2005-12-12

    (243 days)

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

    EASYMED INSTRUMENT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS stands for Transcutaneous Electrical Nerve Stimulation. This TENS system is used to provide symptomatic pain relief for chronic, acute or post operative pain. PMS/EMS stands for Powered Muscles Stimulator/Electrical Muscles Stimulator. This PMS/EMS system is indicated for: - Relaxation of muscle spasm - Increasing local blood circulation - Muscle re-education - Prevention or retardation of disuse atrophy - Prevention of venous thrombosis of the calf muscles immediately after surgery - Maintaining or increasing range of motion
    Device Description
    For the TENS function A portable TENS device for pain relief. For the EMS function A portable EMS device for the re-education of muscles. Features: · Innovative design · Large LCD display • Dual output channels • 2 AA Alkaline Batteries · Adjustable frequency, pulse width, and timing parameters • 9 different modes • Timer option • Doctor lock/unlock facility · Open circuit detectors • Non-volatile
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    K Number
    K040253
    Device Name
    EASY MED TN-28 C
    Manufacturer
    EASYMED INSTRUMENT CO., LTD.
    Date Cleared
    2004-04-08

    (64 days)

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

    EASYMED INSTRUMENT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    T.E.N.S. stands for Transcutaneous Electrical Nerve Stimulation. This T.E.N.S. system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
    Device Description
    T.E.N.S. stands for Transcutaneous Electrical Nerve Stimulation. This T.E.N.S. system is used to provide symptomatic pain relief for chronic, acute or post-operative pain. We do not feel pain until a coded message travels to the brain where it is decoded, analyzed and responded to. The pain message travels from the affected area along small nerve fibers leading into the spinal cord. Here the message is relayed to different nerves that travel up the spinal cord to the brain. The kind provided to you by your personal Transcutaneous Electrical Nerve Stimulator, TN-28C T.E.N.S. Unit consists of sending small electrical pulses through the skin to the body's nervous system. According to the " gate " theory for pain control, the stimulation of large nerve fibers may result in the blocking of pain transmission.
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