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510(k) Data Aggregation

    K Number
    K210441
    Device Name
    Incontinence Probe
    Date Cleared
    2021-09-17

    (217 days)

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

    Shenzhen Med-link Electronics Tech Co, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Incontinence Probes are intended to provide electromyographic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
    Device Description
    The Incontinence Probe models PE0001, PE0002, PE0004, PE0005, PE0006, PE0007 , PE0008, PE0009, and PE0010 are stand-alone probes/electrodes, which can be placed inside the adult rectum or female vagina to transmit electrical stimulation signals or pelvic floor EMG signals when connected to pelvic electrical stimulators or EMG biofeedback devices during the treatment of urinary incontinence . All the models are reusable for a single patient except PE0003, which is a disposable vaginal probe. The probes are not packaged with specific floor muscle stimulators and EMG/biofeedback equipment but are compatible with low-frequency (less than 1000Hz working frequency) stimulators or EMG/biofeedback devices that meet the standards of IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-10 and use 2.0 DIN connection. The probes are made of S304 stainless steel and Acrylonitrile-Butadiene-Styrene (ABS). The probes are designed for use in home or clinic by a single user. The probes do not require sterilization but need cleaning for reuse according to the cleaning instructions provided in the instructions for use manual.
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    K Number
    K181154
    Device Name
    Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor
    Date Cleared
    2019-08-02

    (458 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Med-link Electronics Tech Co, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Med-link Wrist Digital Blood Pressure Monitor is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood presures and pulse rate through an inflatable cuff wrapped around the wrist. It can be used by medical professionals or at home. The cuff circumference is limited to 13.5-19.5 cm. Med-link Upper Arm Digital Blood Pressure Monitor is non-invasive measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood presures and pulse rate through an inflatable cuff wrapped around the upper arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-32cm.
    Device Description
    The proposed devices are battery driven automatic non-invasive blood pressure Monitor. It is used for automatically conduct the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist or upper arm within its claimed range and accuracy by oscillometry technique. Devices are consisted of three main parts: external hardwares (such as cuff), analog circuit, and MCU. The devices have the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The proposed devices are intended to be used in medical facilities or at home and provided non-sterile. The proposed devices have 2 models: Med-link Wrist Digital Blood Pressure Monitor Model:ESM101 Med-link Upper Arm Digital Blood Pressure Monitor Model:ESM201
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