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510(k) Data Aggregation

    K Number
    K123780
    Device Name
    TRANSTEK BLOOD PRESSURE MONITOR
    Manufacturer
    ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
    Date Cleared
    2013-03-01

    (81 days)

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

    ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Transtek Blood Pressure Monitor LS802-E is a digital monitor intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches). This device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. The Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg. Transtek Blood Pressure Monitor, LS802-E is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
    Device Description
    Transtek Blood Pressure Monitor, LS802-E is designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. Measurement 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 heartbeat rate, which is a well-known technique in the market called the "Oscillometric method". Transtek Blood Pressure Monitor is single-mounted devices of 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 22cm and 42 cm. includes the inflatable bladder and nylon shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the purnp, the electromagnetic deflation control valve and the LCD. The subject device is powered by four AA alkaline batteries or by a DC 6V 400mA adapter. The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%. Transtek Blood Pressure Monitor LS802-E embeds a Wireless network connections module that allows it to connect to nearby receiving end (such as specific equipment that named Bridge) which is connected to the Internet. Once measurement is over, the LCD of device displays results. And the device will start to send out data. The Bridge receive / storage, and transmission data to Internet server. Thus users can receive, and display/storage, measurement data from LS802-E unit through their end devices (e.g. PC, cellular, tablet) that connected Internet.
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    K Number
    K123781
    Device Name
    TRANSTEK GLASS BODY FAT ANALYZER
    Manufacturer
    ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
    Date Cleared
    2013-01-09

    (30 days)

    Product Code
    MNW
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Transtek Glass Body Fat Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only.
    Device Description
    Transtek Glass Body Fat Analyzer uses BIA (Bioelectrical Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water, muscle mass and bone mass. The electrical current is low and may not be felt. The current passes freely through the fluids contained in muscle tissue, but encounters difficulty/resistance when it passes through fat tissue. This resistance of the fat tissue to the current is termed 'Bioelectrical Impedance', and is accurately measured by Glass Body Fat Analyzer LS206-E. This method simultaneously calculates your personal weight, body fat, total body water, muscle mass and bone mass, giving you a more accurate reading of your overall health and fitness. This scale stores the personal data of up to 4 users. As well as being an analyzer, this device can be used as a conventional weight scale. Transtek Glass Body Fat Analyzer LS206-E embeds a Wireless network connections module that allows it to connect to nearby receiving end (such as specific equipment that named Bridge) which is connected to the Internet. Once measurement is over, the LCD of device displays results. And the device will start to send out data. The Bridge receive / storage, and transmission data to Internet server. Thus users can receive, and display/storage, measurement results from LS206-E unit through their end devices (e.g. PC, cellular, tablet) that connected Internet.
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    K Number
    K123669
    Device Name
    TRANSTEK WRIST BLOOD PRESSURE MONITOR
    Manufacturer
    ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
    Date Cleared
    2012-12-21

    (22 days)

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

    ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Transtek Wrist Blood Pressure Monitor TMB-1014-BT is a digital monitor intended for use in measuring blood pressure and heartbeat rate in adult patient population with wrist circumference ranging from 13.5 cm to 21.5 cm (about 5 1/4 - 8 1/2 inches). This device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. Wrist Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHz. Transtek Wrist Blood Pressure Monitor, TMB-1014-BT is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
    Device Description
    Transtek Wrist Blood Pressure Monitor, TMB-1014-BT is designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Measurement 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 heartbeat rate, which is a well-known technique in the market called the "Oscillometric method". Transtek Wrist Blood Pressure Monitor is single-mounted devices of the main unit and cuff unit. The preformed cuff unit, which is applicable to wrist circumference approximately between 13.5 and 21.5 cm, includes the inflatable bladder and nylon shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject device is powered by two AAA alkaline batteries. The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%. Transtek Wrist Blood Pressure Monitor TMB-1014-BT embeds a Bluetooth module that allows it to connect to nearby BT receiving end. The LCD of device displays results. And once measurement is over, the device will start transmission data by BT. Thus users can receive, and display/storage, measurement data from TMB-1014-BT unit through their end devices that embedded BT module.
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    K Number
    K122482
    Device Name
    TRANSTEK WRIST BLOOD PRESSURE MONITOR
    Manufacturer
    ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
    Date Cleared
    2012-10-22

    (69 days)

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

    ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This series of devices are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with wrist circumference ranging from 13.5 cm to 21.5 cm (about 5 1/4 -- 8 1/2 inches). This series of devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings. The Wrist Blood Pressure Monitor compares average blood pressure results to pre-established AFIA (American Heart Association) hypertension guideline of 135/85 mmHg. Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-988, TMB-1014, TMB-1117 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
    Device Description
    Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-1014, TMB-1117 are designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Measurement method to define systolic and diastolic pressure is similar to the auscultatory melhod 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 heartbeat rate, which is a well-known technique in the market called the "Oscillometric method". Transtek Wrist Blood Pressure Monitor is single-mounted device of the main unit and cuff unit. The preformed cuff unit, which is applicable to wrist circumference approximately between 13.5 and 21.5 cun, includes the inflatable bladder and nylon shell. All four models of the wrist blood pressure monitor use the same size of cuff. The subject devices consist of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve, and the LCD. The subject devices are powered by two AAA alkaline batteries. The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%.
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    K Number
    K121971
    Device Name
    WITHINGS, SMART BODY SCALE
    Manufacturer
    ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
    Date Cleared
    2012-09-27

    (84 days)

    Product Code
    MNW
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Withings WBS01 Smart Body Scale is a body analyzer that measures weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only.
    Device Description
    WBS01 Smart Body Scale uses the BIA (Bioelectrical Impedance Analysis) technique. This method measures body composition by sending a low, safe electrical current through the body. The current passes freely through the fluids contained in muscle tissue, but encounters difficulty/resistance when it passes through fat tissue. This resistance of the fat tissue to the current is termed 'bioelectrical impedance', and is accurately measured by WBS01 Smart Body Scale. WBS01 Smart Body Scale embeds a 802.11 (Wi-Fi) module that allows it to connect to the Internet. This module is a product add-on that is entirely independent from the body analyzer function, which does not rely on the wireless connection to carry out a bioelectrical impedance analysis and display its results. The scale uses this connectivity to offer users a complementary web and mobile interface to the scale's display, although users are instructed in the provided user manual that the only reference values are the measures displayed on the scale's display. By design. the body analysis and Wi-Fi functions never are enabled at the same time. The scale only connects to the Internet while no weight or bioelectrical impedance measures are being performed, and if a person steps on the scale while the Wi-Fi module is active, Wi-Fi immediately gets turned off therefore allowing the display and body analysis function to be enabled. The users profile details are stored locally in the scale so that they are immediately available when a bioelectrical impedance analysis needs to be performed. The scale without its Wi-Fi module is therefore an autonomous body fat analyzer, Wi-Fi functionality being a product add-on not being part of the body analyzer function and not affecting the safety and effectiveness of the body analyzer function in any way.
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    K Number
    K120058
    Device Name
    TRANSTEK BLOOD PRESSURE MONITOR
    Manufacturer
    ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
    Date Cleared
    2012-01-31

    (22 days)

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

    ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This series of devices are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches). These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings. The Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg. Transtek Blood Pressure Monitor, LS-802, TMB-1018, TMB-1018-A, TMB-1112, and TMB-1112-A models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
    Device Description
    Transtek Blood Pressure Monitor, LS-802, TMB-1018, TMB-1018-A, TMB-1112 and TMB-1112-A are designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the 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 heartbeat rate, which is a well-known technique in the market called the "Oscillometric method". Transtek Blood Pressure Monitor is single-mounted devices of 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 22 and 42 cm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor can use the same two size of cuff (22 - 32cm, or 22 -42cm). Product package will contains only one cuff and which size is decide by business requirement. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by four AAA or AA alkaline batteries or by a DC 6V 400mA adapter. The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%.
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    K Number
    K112932
    Device Name
    TRANSTEK
    Manufacturer
    ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
    Date Cleared
    2011-11-01

    (29 days)

    Product Code
    MNW
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TRANSTEK Glass Body Fat Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only.
    Device Description
    The TRANSTEK Glass Body Fat Analyzer uses BIA (Bio Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water and bone mass. The electrical current is small and may not be felt. Contact with the body is made via glass and stainless steel pads on the platform of the analyzer. This method simultaneously calculates your personal weight, body fat, total body water, bone mass and muscle mass, giving you a more accurate reading of your overall health and fitness. This scale stores the personal data of up to 4 or 8 users. As well as being an analyzer, this device can be used as a conventional scale.
    Ask a Question
    K Number
    K101681
    Device Name
    TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995
    Manufacturer
    ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
    Date Cleared
    2011-05-27

    (346 days)

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

    ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This series of devices are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches). These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings. The Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg. Transtek Blood Pressure Monitor, TMB-986, TMB-987, and TMB-995 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
    Device Description
    Transtek Blood Pressure Monitor, TMB-986, TMB-987, and TMB-995 are designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the 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 heartbeat rate, which is a well-known technique in the market called the "Oscillometric method". Transtek Blood Pressure Monitor is single-mounted devices of 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 22 and 42 cm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor can use the same two size of cuff (22 - 32cm, or 22 - 42cm). Product package will contains only one cuff and which size is decide by business requirement. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by four AAA or AA alkaline batteries or by a DC 6V 400mA adapter. The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%.
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    K Number
    K102191
    Device Name
    TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER
    Manufacturer
    ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
    Date Cleared
    2011-05-02

    (272 days)

    Product Code
    MNW
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Transtek Glass Body Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only.
    Device Description
    The TRANSTEK Glass Body Analyzer uses BIA (Bio Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water and bone mass. The electrical current is small and may not be felt. Contact with the body is made via glass and stainless steel pads on the platform of the analyzer. This method simultaneously calculates your personal weight, body fat, total body water, bone mass and muscle mass, giving you a more accurate reading of your overall health and fitness. This scale stores the personal data of up to 8 or 10 users. As well as being an analyzer, this device can be used as a conventional scale.
    Ask a Question

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