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510(k) Data Aggregation

    K Number
    K052108
    Device Name
    SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100
    Manufacturer
    SEIN ELECTRONICS CO., LTD.
    Date Cleared
    2005-12-07

    (126 days)

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

    SEIN ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BGP-100 blood glucose and blood pressure measurement system consists of a meter with wrist cuff and test strips. The system is intended for use in the quantitative measurement of glucose in whole blood taken from the fingertip. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates. Also the system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillometric method of measurement.
    Device Description
    BGP-100 Sein Blood Glucose & Pressure Monitor system BGP-100 combines the function of a blood glucose monitoring system and a blood pressure meter in one unit. Supplies with the meter are test strips, lancets, lancing device, storage case and control solution. The blood glucose monitoring system is turned on by strip insertion; Once the user confirms that the numerical code on the display, and strip bottle all match, a test strip is inserted into the meter and glucose testing can proceed. The user then supplies finger-tip blood or control solution to the strip and the meter starts the measurement, which is completed in 5 seconds. Sein Electronics Co., Ltd has provided instructions and illustrations explaining, that the blood drop will be pulled into the strip sample entry by capillary action until meter beeps and the result will be show on liquid crystal display ("LCD") after 5 seconds. Results are automatically stored in the meter's memory for tracking purposes. The capacity of memory is 150 blood glucose values and average value of past 14 days or 30days. Control Solution is sold separately from the kit. BGP-100 adopts the wrist type cuff for blood pressure meter part. The cuff and control unit are combined into a single wrist-mounted assembly. The user interface panel has power switch, mode switch, memory switch, for blood pressure meter part and LCD for displaying the systolic blood pressure, diastolic blood pressure, pulse rate, date and time. This device has the memory function that permits memory and display of the 60 most recent measurement results. User should wrap the pressure cuff around the wrist with the palm facing up and pushes the "Power" button. The cuff will be full with appropriate air pressure automatically. Pressurization is automatically governed. If the initial inflation pressure (180mmHg) is inadequate for measurement, i.e. lower that the patient's systolic pressure, the pump will automatically repressurize to a preset level (30 mmHg) above the initial level. Symbols in the LCD indicate pressurization status at all times. The air of cuff is automatically deflated during blood pressure measurement. No special training beyond basic ability to follow instruction is required. Since the products are designed for home use, detailed instructions on avoidance of practices that adversely affect the accuracy of measurements are included in the instruction manual.
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    K Number
    K042138
    Device Name
    FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311
    Manufacturer
    SEIN ELECTRONICS CO., LTD.
    Date Cleared
    2004-08-24

    (15 days)

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

    SEIN ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is an over the counter device, and is indicated for use to measure systolic and diastolic pressure and pulse rate of adults by the individual, in a home care environment, using wrist cuff and oscillometric method of measurement.
    Device Description
    Full Auto Wrist Digital Blood Pressure Monitor SE-311 is intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using wrist cuff and oscillometric method of measurement. There are no contraindications; the subject device may be employed in the care of normotensive, hypertensive, or hypotensive patents. The user interface panel of SE-311 has power button, time button, time button, user button, memory button and liquid crystal display ("LCD") for displaying systolic pressure, diastolic pressure, pulse rate, time, date and user. SE-311 has memory capacity to store the 180 most recent measurement results for four users and the function to transmit the measured data to PC through RS232C cable. The patient is responsible for applying the cuff, for initiating the measurements sequence by pressuring the "Power" button, and for recording results. The patient cannot alter bleed-down rate. All system functions are preprogrammed. The user is cautioned in the instruction manual aqainst attempting any programming or other modification. No special training beyond basic ability to follow instruction is required. Since the products are designed for home use, detailed instructions on avoidance of practices that adversely affect the accuracy of measurements are included in the instruction manual.
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    K Number
    K042014
    Device Name
    DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400
    Manufacturer
    SEIN ELECTRONICS CO., LTD.
    Date Cleared
    2004-08-06

    (10 days)

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

    SEIN ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is an over the counter device, and is indicated for use to measure systolic and diastolic pressure and pulse rate of adults by the individual, in a home care environment, using arm cuff and oscillometric method of measurement.
    Device Description
    Digital Blood Pressure Monitors SE-9000, SE-9200 and SE-9400 are intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using arm cuff and oscillometric method of measurement. There are no contraindications; the subject device may be employed in the care of normotensive, hypertensive, or hypotensive patents. The user interface panels of SE-9200 and SE-9400 have power button, mode button, memory button and liquid crystal display ("LCD") except that SE-9000 has power button, mode/pressure button, memory button, start button. SE-9000, SE-9200 and SE-9400 have memory capacity to store the 140 most recent measurement results. The patient is responsible for applying the cuff, for initiating the measurements sequence by pressuring the "Power" button, and for recording results. The patient cannot alter bleed-down rate. All system functions are preprogrammed. The user is cautioned in the instruction manual against attempting any programming or other modification. No special training beyond basic ability to follow instruction is required. Since the products are designed for home use, detailed instructions on avoidance of practices that adversely affect the accuracy of measurements are included in the instruction manual.
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    K Number
    K032927
    Device Name
    FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR
    Manufacturer
    SEIN ELECTRONICS CO., LTD.
    Date Cleared
    2004-05-07

    (228 days)

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

    SEIN ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is an over the counter device, and is indicated for use to measure systolic and diastolic pressure and pulse rate of adults by the individual, in a home care environment, using arm cuff and oscillometric method of measurement
    Device Description
    SE-7070 is intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using arm cuff and oscillometric method of measurement. There are no contraindications; the subject device may be employed in the care of normotensive, hypertensive, or hypotensive patents. The user interface panel has a power switch, a mode switch, a memory switch and a liquid crystal display ("LCD") for displaying the systolic blood pressure, diastolic blood pressure, pulse rate, date and time. This device has the memory function that permits memory and display of the 58 most recent measurement results. The device measures blood pressure through the use of a automatic inflating cuff. Pressurization is automatically governed. The device has fuzzy logic function that establishes automatically initial inflation pressure according to blood pressures of patients. The cuff automatically deflates during blood pressure measurement. The patient is responsible for applying the cuff, for initiating the measurements sequence by pressuring the "Power" button, and for recording results. The patient cannot alter bleed-down rate. All system functions are preprogrammed. The user is cautioned in the instruction manual against attempting any programming or other modification.
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    K Number
    K012054
    Device Name
    FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312
    Manufacturer
    SEIN ELECTRONICS CO., LTD.
    Date Cleared
    2001-08-08

    (37 days)

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

    SEIN ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To measure of systolic and diastolic blood pressure and pulse rates of adults using wrist cuff and oscillometric method.
    Device Description
    Full Auto Wrist Digital Blood Pressure Monitor, SE-312
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    K Number
    K003711
    Device Name
    AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P
    Manufacturer
    SEIN ELECTRONICS CO., LTD.
    Date Cleared
    2000-12-15

    (14 days)

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

    SEIN ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003282
    Device Name
    FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H
    Manufacturer
    SEIN ELECTRONICS CO., LTD.
    Date Cleared
    2000-11-01

    (13 days)

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

    SEIN ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991397
    Device Name
    TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS
    Manufacturer
    SEIN ELECTRONICS CO., LTD.
    Date Cleared
    2000-02-11

    (296 days)

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

    SEIN ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    the SEIN SE-30 TENS device is indicated for the symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
    Device Description
    Proprietary Name : SE-30 TENS Common or Usual Name : Transcutaneous Electrical Nerve Stimulator Classification Name : Stimulator, Nerve, Transcutaneous (Pain Relief) The SEIN SE-30 TENS device is equivalent to the Graham-Field, Inc. Micro TENS Plus transcutaneous electrical nerve stimulator. Each product is used for the symptomatic relief of and management of long term intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain. One output channel, Asymmetric bi-phasic & phasic rectangular shape with zero net direct current, Pulse Width 105-450 us programmed insert protected circuit, Pulse Rate 1-200 pulse/sec programmed, Power Source two alkaline AAA batteries 1.5 volt, Maximum Voltage Load 200 ohm 26 V, 500 ohm 40 V, 1 Kohm 52 V, open 90 V, Maximum Output charge/pulse (500 ohm load for safety) 58.5 uc/pulse, Maximum Output average current (500 ohm load for safety) 3.375 mA, Size 70(W) x 79(H) x 17(D) mm, Weight 80 grams, Recharge Battery Option N, Battery Check N, Water Use Option N, Discriminate Polality Automatically Change, Gel Pad Adhesive Type, Treatment 15 min. (no daily limit), MODES AVAILABLE Mode 1: [Modulation] 1. Pulse Rate : 1-100 pps 2. Pulse Width: 220-450 usec, Mode 2... [Burst] 1. Pulse Rate: 16 pulse/burst. 4b/sec 16 pulse/burst. 7b/sec 63-125 pps 2. Pulse Width : 105-450 usec, Mode 3... [Modulation] 1. Pulse Rate : 1-5 pps 2. Pulse Width : 220 usec, Mode 4... [Burst] 1. Pulse Rate: 220 pulse/burst, 1b/sec 90 pulse/burst. 1b/sec 2. Pulse Width: 220-450 usec
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    K Number
    K973078
    Device Name
    WRIST BLOOD PRESSURE METER MODEL SE-330
    Manufacturer
    SEIN ELECTRONICS CO., LTD.
    Date Cleared
    1999-05-20

    (640 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEIN ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the measurement of systolic and diastolic blood pressure and pulse rate in adult patients.
    Device Description
    The SEIN SE-330 Wrist Blood Pressure Meter is a semi-automatic electronic device designed to measure blood pressure and pulse, and in which a compact wrist cuff is used in place of the standard wrist cuff. Inflation and deflation are accomplished through the use of a manual inflation bulb and solenoid valve respectively. Blood pressure and pulse are measured using the oscillometric method. A liquid crystal display of up to six digits is employed to record blood pressure and pulse. Power is supplied by two lithium batteries (size CR2032). Built-in memory allows the display of the previously measured blood pressure and pulse values for comparison to current measurements. An automatic power cut-off feature after one minute of non-use is built into the device to permit saving of energy. The measuring range of the device is 20-280 mmHg (pressure) and 40-200 pulses per minute with an accuracy of +3mmHg or 2% of the reading, whichever is greater, for the pressure and t5% of the reading for pulse. The dimensions of the SE-330 Blood Pressure Meter are 58 mm (W) and 70 mm (D) x 23.8 mm (H). The weight of the meter is approximately 110 g including two batteries. The wrist cuff dimensions are 314.7 mm (1) x 70 mm (w). Battery life for the device is approximately 150 measurements.
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    K Number
    K952826
    Device Name
    FULL AUTO FUZZY BLOOD PRESSURE METER MODEL SE-7000
    Manufacturer
    SEIN ELECTRONICS CO., LTD.
    Date Cleared
    1996-11-14

    (513 days)

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

    SEIN ELECTRONICS CO., LTD.

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