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510(k) Data Aggregation

    K Number
    K243118
    Device Name
    Arm Blood Pressure Monitor (model: BPM-A7VL)
    Manufacturer
    Shenzhen IMDK Medical Technology Co., Ltd.
    Date Cleared
    2024-11-26

    (57 days)

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

    Shenzhen IMDK Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of person older than twelve (12) years in household or medical facilities.
    Device Description
    Arm Blood Pressure Monitor, model: BPM-A7VL is a Noninvasive Blood Pressure Measurement System that is intended for measuring blood pressure through oscillation mensuration. The subject device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited. lt measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The BPM-A7VL is small, portable and used in home or medical facilities environment. The Arm Blood Pressure Monitor consists of two parts: main unit and cuffs. The BPM-A7VL is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 23cm~33cm and cuff of size 33cm~47cm.
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    K Number
    K233040
    Device Name
    EMS/TENS Massager Device
    Manufacturer
    Shenzhen IMDK Medical Technology Co., Ltd.
    Date Cleared
    2024-02-12

    (140 days)

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

    Shenzhen IMDK Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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 or facilitate muscle performance.
    Device Description
    Not Found
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    K Number
    K221979
    Device Name
    Pulse Oximeter (Model C101A2, C101B1, C101A3)
    Manufacturer
    Shenzhen IMDK Medical Technology CO., Ltd.
    Date Cleared
    2022-10-16

    (103 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen IMDK Medical Technology CO., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fingertip Pulse Oximeter (Model:C101A2,C101B1,C101A3) is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in hospitals.
    Device Description
    SpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO2 measuring unit. The light-electronic transducer in finger sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal, the signal is processed by hardware and software of the unit. The PLETH curve and numeral value of SpO2 will be obtained. The pulse oximeter, model C101A2, C101B1, C101A3 is designed for spot checking of the pulse oxygen saturation and pulse rate for adults in a clinic environment. This medical device can be reused. Not for continuously monitoring. The device is not for life-supporting or life-sustaining, not for implant. The device is not provided sterile and is NOT a reprocessed single-use device. The device is a spot-check pulse oximeter and does not include alarms. The device does not support the measurement in the condition of low perfusion. The device is not intended for life-supporting or life-sustaining. The device is reusable and does not need sterilization.
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    K Number
    K173123
    Device Name
    Pulse Oximeter
    Manufacturer
    Shenzhen IMDK Medical Technology Co., Ltd.
    Date Cleared
    2018-08-13

    (318 days)

    Product Code
    DQA, DOA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen IMDK Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fingertip Pulse Oximeter C101H1 is a non-invasive device intended for spot checking of function of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in hospitals.
    Device Description
    SpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO2 measuring unit. The light-electronic transducer in finger sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal is processed by hardware and software of the unit. The PLETH curve and numeral value of SpO2 will be obtained. The pulse oximeter, C101H1, is designed for spot checking of the pulse oxygen saturation and pulse rate for adults in a clinic environment. This medical device can be reused. Not for continuously monitoring. The device is not for life-supporting or life-sustaining, not for implant. The device is not provided sterile and is NOT a reprocessed single-use device. The device is a spot-check pulse oximeter and does not include alarms. The device does not support the measurement in the condition of low perfusion. The device is not intended for life-supporting or life-sustaining. The device is reusable and does not need sterilization.
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    K Number
    K180419
    Device Name
    Ultrasonic Doppler (Model YM-2T8)
    Manufacturer
    Shenzhen IMDK Medical Technology Co., Ltd.
    Date Cleared
    2018-07-19

    (154 days)

    Product Code
    KNG
    Regulation Number
    884.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen IMDK Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ultrasonic Doppler uses continuous-wave Doppler to detect fetal heart rate and play the fetal heart sound from early gestation thru delivery for singleton pregnancies. The Ultrasonic Doppler is intended for use by trained healthcare professionals only in a clinical setting.
    Device Description
    The Ultrasonic Doppler is a hand-held device for non-invasive measurement and display of the fetal heart beat utilizing the principle of Doppler shift of an ultrasound. The device consists of two main components, the main unit and probe. The main unit consists of the main board, power module, battery, speaker, and organic light-emitting diode screen. The wired probe consists of the transducer and includes two angled semi-circle ultrasonic crystals, one for transmission and one for reception. The ultrasonic signal is continuously transmitted at a frequency of 2 MHz. The reflected continuous wave signal is received by one of the crystals and then any detected Doppler shift is presented to the user. The main unit is powered by two 1.5V AA alkaline batteries.
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