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510(k) Data Aggregation

    K Number
    K243060
    Device Name
    TeleRPM Gen2 Blood Glucose Monitoring System
    Manufacturer
    Guangdong Transtek Medical Electronics Co., Ltd.
    Date Cleared
    2025-01-30

    (125 days)

    Product Code
    NBW
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangdong Transtek Medical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TeleRPM Gen2 Blood Glucose Monitoring System is comprised of the TeleRPM Gen2 Blood Glucose Meter and the TeleRPM Blood Glucose Test Strips. TeleRPM Gen2 Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
    Device Description
    TeleRPM Gen2 Blood Glucose Monitoring System consists of TeleRPM Gen2 Blood Glucose Meter and the TeleRPM Blood Glucose Test Strips. TeleRPM Control Solution, TeleRPM Lancing Device, TeleRPM Lancets are required for use but not included in meter box or test strips box and should be purchased separately. The TeleRPM Control Solution is for use with the above meter and test strip as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly. TeleRPM Lancing Device and TeleRPM Lancets are used for puncturing fingertip and then user can perform qlucose test with blood sample. TeleRPM Gen2 Blood Glucose Monitoring System is designed to quantitatively measure the glucose concentration in fresh capillary whole blood from the fingertip. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose oxidase and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration value is reported in plasma equivalents and is displayed on meter screen.
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    K Number
    K241351
    Device Name
    Blood Pressure Monitor (TMB-2092-G)
    Manufacturer
    Guangdong Transtek Medical Electronics Co., Ltd.
    Date Cleared
    2024-08-21

    (100 days)

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

    Guangdong Transtek Medical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Blood Pressure Monitor is intended for use in measuring blood pressure and pulse rate in patients with arm circumferences from 16 to 36 cm (6.3 to 14.1 inch), 22 to 42cm (8.6 to 16.5 inch), 22 to 45cm (8.6 to 17.7 inch) or 40 to 52cm (15.7 to 20.5 inch). Cuff model AC1636-01, arm circumference range is 16-36cm (6.3 to 14.1 inch), which is intended for children older than 3 years old or adults without conditions of diabetes, pregnancy, or preeclampsia. Cuff model AC2245-021, arm circumference range is 22~45cm (8.6 to 17.7 inch), which is intended for adult population or those who with conditions of diabetes, pregnancy, or pre-eclampsia. Cuff model AC2242-41 and cuff model AC4052-04, arm circumference range are 22-42cm (8.6 to 16.5 inch) and 40~52cm (15.7 to 20.5 inch) respectively, which are intended for adults without conditions of diabetes, pregnancy, or pre-eclampsia. It is intended indoor use only.
    Device Description
    The Blood Pressure Monitor is designed to measure the systolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method". The main components of the Blood Pressure Monitor is the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 160mm and 520 mm, includes the inflatable bladder and polyester shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the electromagnetic deflation control valve and the LCD. The devices embed a Cellular Wireless network connections module that allows it to connect to receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse rate, date and time by Wireless method and protocol.
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    K Number
    K240832
    Device Name
    Blood Pressure Monitor (BBZ32-AA01)
    Manufacturer
    Guangdong Transtek Medical Electronics Co., Ltd.
    Date Cleared
    2024-06-07

    (73 days)

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

    Guangdong Transtek Medical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with arm circumference ranging from 22cm to 32cm (about 8¾ -12½´) or 22cm to 42cm (about 834"-161/2"). It is intended for adult indoor use only.
    Device Description
    Blood Pressure Monitor BBZ32-AA01 is designed to measure systolic pressure, diastolic pressure and pulse rate of adult by a non-invasive technique, with an inflatable cuff wrapped around the upper arm. The method to define systolic and diastolic pressure is similar to auscultatory method, though it uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alternations of cuff pressure into electrical signals. Based on analysis of these signals, the systolic and diastolic blood pressure is defined, and the pulse rate is calculated. This is an extensively used technique applied in blood pressure monitors, also known as "oscillometric method". The main components of the Blood Pressure Monitor include main unit and cuff. For the outer housing of the main unit, it's made of HIPS material. As for accompanying cuffs, two types of cuffs have been clinically validated to be matched with the device, suitable for adults with arm circumference from 22cm~42cm. The cuff is consisted of fabric and an inflatable bladder inside. For critical electronic components, there is PCB, thermistor, pressure pump, motor, release valve and pressure sensor. The device also enjoys a function of detecting irregular pulse rate. When measurements were performed, the monitor will record all pulse intervals and calculate the average. If two or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±25% of the average; or if four or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±15% of the average, the irregular pulse symbol will be displayed along with measurement results. An embedded Bluetooth wireless connection module in the device allows it to connect with matching receiving ends. When a measurement is done, the results will be displayed on LCD, and the measured data will be transferred to the APP via Bluetooth.
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    K Number
    K240254
    Device Name
    Blood Pressure Monitor (TMB-2296-BT)
    Manufacturer
    Guangdong Transtek Medical Electronics Co., Ltd.
    Date Cleared
    2024-05-31

    (121 days)

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

    Guangdong Transtek Medical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with arm circumference ranging from 22cm to 32cm (about 8¾"-12½") or 22cm to 42cm (about 8¾"-16½"). It is intended for adult indoor use only.
    Device Description
    Blood Pressure Monitor TMB-2296-BT is designed to measure systolic pressure, diastolic pressure and pulse rate of adult by a non-invasive technique, with an inflatable cuff wrapped around the upper arm. The method to define systolic and diastolic pressure is similar to auscultatory method, though it uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alternations of cuff pressure into electrical signals. Based on analysis of these signals, the systolic and diastolic blood pressure is defined, and the pulse rate is calculated. This is an extensively used technique applied in blood pressure monitors, also known as "oscillometric method". The main components of the Blood Pressure Monitor include main unit and cuff. For the outer housing of the main unit, it's made of HI-121H material. The two types of cuffs have been clinically validated to be matched with the device, suitable for adults with arm circumference from 22cm~42cm. The cuff is consisted of fabric and an inflatable bladder inside. For critical electronic components, there is medical switch power supply, PCB, thermistor, pressure pump, motor, release valve and pressure sensor. The device also enjoys a function of detecting irregular pulse rate. When measurements were performed, the monitor will record all pulse intervals and calculate the average. If two or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±25% of the average; or if four or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±15% of the average, the irregular pulse symbol will be displayed along with measurement results. An embedded Bluetooth wireless connection module in the device allows it to connect with matching receiving ends. When a measurement is done, the results will be displayed on LCD, and the measured data will be transferred to the APP via Bluetooth.
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    K Number
    K240102
    Device Name
    Blood Pressure Monitor (TMB-2287-B)
    Manufacturer
    Guangdong Transtek Medical Electronics Co., Ltd.
    Date Cleared
    2024-04-29

    (104 days)

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

    Guangdong Transtek Medical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with arm circumference ranging from 22cm to 32cm (about 8¾˜-12½´´), 22cm to 42cm (about 8% -16½"), 22cm to 45cm (about 8¾ -17¾ ") or 40cm to 52cm (about 15¾ -20½ "). It is intended for adult indoor use only.
    Device Description
    Blood Pressure Monitor TMB-2287-B is designed to measure systolic pressure, diastolic pressure and pulse rate of adult by a non-invasive technique, with an inflatable cuff wrapped around the upper arm. The method to define systolic and diastolic pressure is similar to auscultatory method, though it uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alternations of cuff pressure into electrical signals. Based on analysis of these signals, the systolic and diastolic blood pressure is defined, and the pulse rate is calculated. This is an extensively used technique applied in blood pressure monitors, also known as "oscillometric method". The main components of the Blood Pressure Monitor include main unit and cuff. For the outer housing of the main unit, it's made of HIPS material. As for accompanying cuffs, five types of cuffs have been clinically validated to be matched with the device, suitable for population aged at or over three and with arm circumference from 22cm~52cm. The cuff is consisted of fabric and an inflatable bladder inside. For critical electronic components, there is medical switch power supply, PCB, thermistor, pressure pump, motor, release valve and pressure sensor. The device also enjoys a function of detecting irregular pulse rate. When measurements were performed, the monitor will record all pulse intervals and calculate the average. If two or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±25% of the average; or if four or more pulse intervals were recorded, and the difference between each interval and the average is larger than ± 15% of the average, the irregular pulse symbol will be displayed along with measurement results. An embedded Bluetooth wireless connection module in the device allows it to connect with matching receiving ends. When a measurement is done, the results will be displayed on LCD, and the measured data will be transferred to the APP via Bluetooth. With the use of software (including APP) and Bluetooth communication module, the wireless software function and hardware function are solely intended to transfer, store, convert formats, or display medical device data and results (blood pressure and pulse rate readings), without controlling or altering the functions or parameters of any connected medical devices, which is not be intended for active patient monitoring, therefore, based on the FDA guidance titled "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices" (issued on September 28, 2022.), this software function is belong to Non-device-MDDS, and the hardware function is belong to Device-MDDS, they are not subject to FDA laws and regulations applicable to devices.
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    K Number
    K233130
    Device Name
    Blood Pressure Monitor
    Manufacturer
    Guangdong Transtek Medical Electronics Co., Ltd.
    Date Cleared
    2023-12-20

    (84 days)

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

    Guangdong Transtek Medical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blood Pressure Monitor is a digital monitor in measuring blood pressure and pulse rate with a wrist circumference ranging from 13.5cm to 21.5cm (about 51/3"-81/2"). It is intended for adult indoor use only.
    Device Description
    Blood Pressure Monitor TMB-2285-BT is designed to measure systolic pressure, diastolic pressure and pulse rate of adult population by a non-invasive technique, with an inflatable cuff wrapped around the wrist. The method to define systolic and diastolic pressure is similar to auscultatory method, though it uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alternations of cuff pressure into electrical signals. Based on analysis of these signals, the systolic and diastolic blood pressure is defined, and the pulse rate is calculated. This is an extensively used technique applied in blood pressure monitors, also known as "oscillometric method". The main components of the Blood Pressure Monitor include main unit and wrist cuff. For the outer housing of the main unit, it's made of ABS material. The cuff model is WC1321-04, suitable for adults with wrist circumference of 13.5cm to 21.5cm. The cuff is consisted of fabric and an inflatable bladder inside. For critical electronic components, there is PCB, thermistor, pressure pump, motor, release valve and pressure sensor. The device also enjoys a function of detecting irregular pulse rate. When measurements were performed, the monitor will record all pulse intervals and calculate the average. If two or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±25% of the average; or if four or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±15% of the average, the irregular pulse symbol will be displayed along with measurement results. An embedded Bluetooth wireless connection module in the device allows it to connect with matching receiving ends. When a measurement is done, the results will be displayed on LCD, and the measured data will be transferred to the APP via Bluetooth.
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    K Number
    K232713
    Device Name
    Blood Pressure Monitor
    Manufacturer
    Guangdong Transtek Medical Electronics Co., Ltd.
    Date Cleared
    2023-11-28

    (84 days)

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

    Guangdong Transtek Medical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with arm circumference ranging from 16cm to 36cm (about 6½"-14½"), 22cm to 32cm (about 8¾"-12½"), 22cm to 42cm (about 8¾"-16½") or 22cm to 45cm (about 8¾"-17¾"). The cuff with arm circumference range of 16~36cm is intended for children older than 6 years old or adults. The cuffs with arm circumference range of 22~32cm or 22~42cm or 22~45cm, which are intended for adult population. It is intended indoor use only.
    Device Description
    Blood Pressure Monitor TMB-2266 is designed to measure systolic pressure, diastolic pressure and pulse rate of population at or over 3 years old by a non-invasive technique, with an inflatable cuff wrapped around the upper arm. The method to define systolic and diastolic pressure is similar to auscultatory method, though it uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alternations of cuff pressure into electrical signals. Based on analysis of these signals, the systolic and diastolic blood pressure is defined, and the pulse rate is calculated. This is an extensively used technique applied in blood pressure monitors, also known as "oscillometric method". The main components of the Blood Pressure Monitor include main unit and cuff. For the outer housing of the main unit, it's made of HIPS material. As for accompanying cuffs, five types of cuffs have been clinically validated to be matched with the device, suitable for population aged at or over three and with arm circumference from 16cm~45cm. The cuff is consisted of fabric and an inflatable bladder inside. For critical electronic components, there is medical witch power supply, PCB, thermistor, pressure pump, motor, release valve and pressure sensor. The device also enjoys a function of detecting irregular pulse rate. When measurements were performed, the monitor will record all pulse intervals and calculate the average. If two or more pulse intervals were recorded, and the difference between each interval and the average is larger than ± 25% of the average; or if four or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±15% of the average, the irregular pulse symbol will be displayed along with measurement results. An embedded Bluetooth wireless connection module in the device allows it to connect with matching receiving ends. When a measurement is done, the results will be displayed on LCD, and the measured data will be transferred to the APP via Bluetooth.
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    K Number
    K232621
    Device Name
    Blood pressure monitor
    Manufacturer
    Guangdong Transtek Medical Electronics Co., Ltd.
    Date Cleared
    2023-11-22

    (85 days)

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

    Guangdong Transtek Medical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Blood Pressure Monitor is intended for use in measuring blood pressure and pulse rate in patients with arm circumferences from 16 to 36 cm (6.3 to 14.1 inch) or 22 to 45cm (8.6 to 17.7 inch). Cuff model AC1636-01, arm circumference range is 16-36cm (6.3 to 14.1 inch), which is intended for children older than 3 years old or adults without conditions of diabetes, pregnancy, or pre-eclampsia. Cuff model AC2245-021, arm circumference range is 22-45cm (8.6 to 17.7 inch), which is intended for adult population or those who with conditions of diabetes, pregnancy, or pre-eclampsia. It is intended indoor use only.
    Device Description
    The Blood Pressure Monitor is designed to measure the systolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method". The main components of the Blood Pressure Monitor is the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 160mm and 450 mm, includes the inflatable bladder and polyester shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the electromagnetic deflation control valve and the LCD. The devices embed a Cellular Wireless network connections module that allows it to receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse rate, date and time by Wireless method and protocol.
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    K Number
    K223374
    Device Name
    Blood Pressure Monitor
    Manufacturer
    Guangdong Transtek Medical Electronics Co., Ltd.
    Date Cleared
    2023-06-30

    (238 days)

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

    Guangdong Transtek Medical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a digital monitor intended for use in measuring blood pressure and pulse rate. The device is intended to be used in a human adult population with an arm circumference of 9 inches (22 cm to 42 cm). The device is intended for indoor use.
    Device Description
    The Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "Oscillometric method". When using the device, users will be able to monitor their blood pressure and their pulse rate. The device will give metrics about heart health: - Systolic blood pressure - Diastolic blood pressure - Pulse rate The device should be placed on the left upper arm during all the measurement duration. The measurement lasts between 30 seconds and 3 minutes depending on the selected mode by the user. The measurement can be longer if the user selects the triple measurement mode (three blood pressure measurements in a row to give an average). Users will get an instant feedback after the measurement thanks to a LED matrix located on the tube part of the device. WPM05 (BPM Connect) The device synchronizes with Withings application and Withings server via Bluetooth or Wi-Fi connectivity. WPM06 (BPM Connect Pro) The device synchronizes with third-party applications by cellular, Wi-Fi or Bluetooth connectivity. On the mobile application, users have access to their historic and more contents around each metrics.
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    K Number
    K220676
    Device Name
    Blood Pressure Monitor
    Manufacturer
    Guangdong Transtek Medical Electronics Co., Ltd.
    Date Cleared
    2022-08-29

    (174 days)

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

    Guangdong Transtek Medical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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