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510(k) Data Aggregation
K Number
K140762Device Name
AUTOMATIC BLOOD PRESSURE MONITOR
Manufacturer
JAWON MEDICAL CO., LTD.
Date Cleared
2015-07-02
(462 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
JAWON MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Jawon Upper Arm Automatic Digital Blood Pressure Monitor, Model EX PLUS 1300 is for use by medical professional or home user. The EX PLUS 1300 is a device intended to measure the systolic and diastolic blood pressure, pulse rate and mean blood pressure and inter-arm pressure difference of an adult individual by using a non-invasive oscillometric technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s). The cuff size is fit for arm circumference of 23-36 cm.
Device Description
The EX PLUS 1300 is a blood pressure monitor to non-invasively measure blood pressures and heart rate at the brachial site(s). The device employs oscillometric method. The device is a microprocessor-controlled and includes an air pump, an electronic valve to regulate deflation rate, circuitry to detect and process minute pressure oscillations, LCD display of systolic and diastolic pressure readings and heart rate, and push buttons. The device employs a pressurement algorithm designed to detect, filter, process, and store pressure readings. The electronic deflation control valve maintains the deflation rate within limits of 3 to 5 mmHg/sec to optimize measurement accuracy. The EX PLUS 1300 is an AC adapter-powered.
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K Number
K140045Device Name
BODY COMPOSITION ANALYZER
Manufacturer
JAWON MEDICAL CO., LTD.
Date Cleared
2015-02-18
(406 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
JAWON MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These devices calculates and estimates body composition parameters by using measured weight and impedance and entered height, age and gender. It shows body composition of Weight, Standard weight, Lean Body Mass, Total Body Water, Intra Cellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat, Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control, Goal setter.
In case of whole body, it shows more items including Waist to Hip Ratio, Ratio of E.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk).
These devices can only estimate the body composition parameters with the exception of Weight, BMI, and impedance. These devices are only for use with generally healthy individuals of a specified age range.
Device Description
These devices calculates and estimates body composition parameters by using measured weight and impedance and entered height, age and gender. It shows body composition of Weight, Standard weight, Lean Body Mass, Total Body Water, Intra Cellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat, Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control, Goal setter.
In case of whole body, it shows more items including Waist to Hip Ratio, Ratio of E.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk).
These devices can only estimate the body composition parameters with the exception of Weight, BMI, and impedance. These devices are only for use with generally healthy individuals of a specified age range.
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K Number
K092432Device Name
AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L)
Manufacturer
JAWON MEDICAL CO., LTD.
Date Cleared
2009-10-09
(63 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
JAWON MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients with age 16 or order and arm circumference range between 9" to 14" (23cm to 36cm).
Device Description
The EASY X 800 (R/L) and EASY 900 (R/L) are blood pressure monitors to non-invalied. The devices of The EAST X 600 (102) and EXS P 500 (102) The devices employ oscillometric method. The devices are airsuing microprocessor-controlled and include an air pump, an electronic valve to regulate deflation and controlled of microprocessor-controlled and included and in and in and in the many of LCD(EASY X 900) display of systolic and diastolic pressure readings and heart rate, and push buttons. Systom and dastone proboard roading of the designed to detect, filter, filter, process, and store The devices employ a probation control valve maintains the deflation rate within limits of 3 to 5 mmHg/sec to optimize measurement accuracy. The EASY X 800 (R/L) and EASY X 900 (R/L) are AC adapter-powered.
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K Number
K092431Device Name
BODY COMPOSITION ANALYZER, MODEL: IOI 353
Manufacturer
JAWON MEDICAL CO., LTD.
Date Cleared
2009-10-08
(62 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
JAWON MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), TBW(Total Body Water), BMI(Body Mass Index), BMR(Basic Metabolic Rate), Segmental LBM, ICW(Intra-Cellular Water), ECW(Extra-Cellular Water), and ratio of ECW/TBW using the BIA(Bio-electrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, and WHR(Waist to Hip Ratio) of the user.
This device is intended for use only in healthy subjects between the age of 7-89.
Device Description
The ioi 353 is body composition analyzer is intended for use only in healthy subjects between the age of 7-89. The device employs BIA(Bio-electrical Impedance Analysis) method and 8 electrodes placed on hands and feet, and then measure body composition using an experimentally derived algorithm. The device is powered by AC adapter.
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K Number
K072325Device Name
BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205
Manufacturer
JAWON MEDICAL CO., LTD.
Date Cleared
2007-11-30
(102 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
JAWON MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EasyBody 202 and EasyBody 203 are intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), recommended daily calorie intake, daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method.
The EasyBody 205 is intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), Segmental LBM, recommended daily calorie intake, daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method.
The EasyBody 202, EasyBody 203 and EasyBody 205 measure the impedance and weight of the user, and are intended for use only in healthy subjects between the age of 5-89.
Device Description
The EasyBody 202, EasyBody 203 and EasyBody 205 are non-invasive body composition analyzers intended for use only in healthy subjects between the age of 5-89. The devices employ BIA(Bio-electrical Impedance Analysis) method, 4 electrodes for EasyBody 202 and EasyBody 203, 8 electrodes for EasyBody 205, and then measure body composition using an experimentally derived algorithm. The devices are powered by four AA batteries (DC 6V) or AC adapter.
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K Number
K071884Device Name
BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900
Manufacturer
JAWON MEDICAL CO., LTD.
Date Cleared
2007-08-09
(31 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
JAWON MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These devices are intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), TBW(Total Body Water), BMI(Body Mass Index), BMR(Basic Metabolic Rate), Segmental LBM, ICW(Intra-Cellular Water), ECW(Extra-Cellular Water), and ratio of ECW/TBW using the BIA(Bio-electrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, and WHR(Waist to Hip Ratio) of the user.
These devices are intended for use only in healthy subjects between the age of 7-89.
Device Description
The X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500 and XBIA 900 are body composition analyzers intended for use only in healthy subjects between the age of 7-89. The devices employ BIA(Bio-electrical Impedance Analysis) method and 8 electrodes placed on hands and feet (or ankles), and then measure body composition using an experimentally derived algorithm. For only XBIA 500, optional ankle electrode is not supplied. The devices are powered by AC100~230V 50/60Hz.
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K Number
K062462Device Name
NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L
Manufacturer
JAWON MEDICAL CO., LTD.
Date Cleared
2006-09-29
(36 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
JAWON MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients with age 16 or older and arm circumference range between 9" to 14"(23cm to 36cm).
Device Description
Models FT-500 and FT-700 of the Jawon system are compact, automatic sphygmomanometers intended for measurement of blood pressure at the brachial site. Models FT-500 and FT-700 employ oscillometric method. All models are microprocessor controlled and include an air pump, an electronic valve to regulate deflation rate, circuitry to detect and process minute pressure oscillations, an LCD display of systolic and diastolic pressure readings and heart rate, and push button controls.
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K Number
K053556Device Name
BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5
Manufacturer
JAWON MEDICAL CO., LTD.
Date Cleared
2006-08-31
(254 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
JAWON MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ZEUS 9.9 and VENUS 5,5 body composition analyzers are intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), TBW(Total Body Water), BMI(Body Mass Index), BMR(Basic Metabolic Rate), Segmental LBM, ICW(Intra-Cellular Water), ECW(Extra-Cellular Water), and ratio of ECW/TBW using the BIA(Bio-electrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, and WHR(Waist to Hip Ratio) of the user.
These devices are intended for use only in healthy subjects between the age of 7-89.
The only difference between the ZEUS 9.9 and VENUS 5.5 is head part of main unit; that is, the head part of the ZEUS 9.9 has a key pad and touch screen while the head part of the VENUS 5.5 has only a touch screen
Device Description
Model ZEUS 9.9/VENUS 5.5 of Jawon Medical is compact, automatic General: Impedance plethysmographer intended for estimating of body composition of user such as PBF(Percentage of Body Fat), MBF(Mass of Sody Fat), LBM(Lean Body Mass), TBW(Total Body Water), BMI(Body Mass Index), BMR(Basic Metabolic Rate), Segmental LBM, ICW(Intra-Cellular water), ECW(Extra-Cellular Water), and ratio of ECW/TBW using the BIA/Bioelectrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, and WHR(Waist to Hin Ratio) of the user. These devices are intended for use only in healthy subjects between age of 7-89. The only difference between the ZEUS 9.9 and VENUS 5.5 is head part of main unit; that is, the head part of the ZEUS 9.9 has a key pad and touch screen while the head part of the VENUS 5.5 has only a touch screen.
Operation: The subject device employs a measurement algorithms which is called BIA method, to measure user's body composition.
ZEUS 9.9/VENUS 5.5 device's tetra-polar type electrode connect to human body and then send an minute electric current like 360 A human body and then ZEUS 9.9/VENUS 5.5 device can measure impedance of the human body.
ZEUS 9.9/VENUS 5.5 can measure body composition of user with personal data which already saved height, weight, gender, ages and new calculated body impedance.
Power: Model ZEUS 9.9/VENUS 5.5 is AC line powered(AC 110~120V, 50/60Hz)
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K Number
K013876Device Name
INFRARED EAR THERMOMETER, MODEL DX-707
Manufacturer
JAWON MEDICAL CO., LTD.
Date Cleared
2002-03-04
(101 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
JAWON MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Infrared Ear Thermometer, Model DX-707 is intended for the intermittent measurement of human body temperature in home care environment. It is intended for use on people of all ages.
Device Description
The DX-707 Infrared Ear Thermometer is a hand-held, non-sterile, reusable clinical thermometer using an infrared sensor that measures patient body temperature through the opening of the auditory canal. Its operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces. The DX-707 Infrared Ear Thermometer consists mainly of five parts with the associated circuit: (1) IR sensor, (2) Micom IC, (3) LCD module, (4) an ambient temperature sensor (thermistor), and (5) Keys, "I/O", "Measure". The DX-707 thermometer is powered by internal DC 3V battery, size CR2032 and it is supplied with probe cover.
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K Number
K002722Device Name
DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505
Manufacturer
JAWON MEDICAL CO., LTD.
Date Cleared
2000-09-11
(11 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
JAWON MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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