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510(k) Data Aggregation
K Number
K082254Device Name
MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
Manufacturer
BODYSTAT LTD.
Date Cleared
2011-02-07
(913 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
BODYSTAT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the purposes of performing a non-invasive BIA measurement on normal healthy human adults and children to determine their Body Composition status.
The measurements include Body Mass Index (BMI), waist/hip ratio, tissue impedance at 5kHz and at 50kHz. These measurements are used to calculate the estimated levels of body fat, body lean and dry lean, total body water, and metabolic rates,
Bodystat BODY MANAGER and WELLNESS SOFTWARE PROGRAMS are automatically included with this device.
The Body Manager Program is designed for when a client returns to be tested in order to track their changes in body composition over a period of time.
The Wellness Program is designed for first time assessments on subjects. The program's graphical presentations provide information on each of the specific measurements in an educational format.
Device Description
The Bodystat 1500MDD Body Composition Monitoring Unit is a light weight, handheld, batteryoperated device that uses bio-electrical impedance analysis (BIA) to measure the impedance of the flow of an electrical current through the body. The impedance of tissue is proportional to the amount of fluid in the tissue; water is low in fat tissues, thus fat tissue has a high impedance, and high in lean tissues, thus lean tissue has a low impedance. The subject's age, sex, height, waist measurement, and hip measurement are also used to calculate various values.
In practice, a small constant current is passed between electrodes spanning the body and the voltage drop between electrodes provides a measure of impedance. Prediction equations, previously generated by correlating impedance measures against an independent estimate of TBW (total body water), may be used subsequently to convert a measured impedance to a corresponding estimate of TBW. Lean body mass is then calculated from this estimate using an assumed hydration fraction for lean tissue; Bodystat uses a proprietary regression equation for this calculation. Fat mass is calculated as the difference between body weight and lean body mass. A body composition analysis report is comprised of Body Fat, Lean Body Mass, Dry Lean Mass, Total Body Water, and Optimal Ranges. Metabolic rates, Waist/Hip Ratio, and BMI are also reported. In addition, raw values are shown for Impedance at 5 kHz and at 50 kHz. The Bodystat 1500MDD contains separate equations for children aged 6 - 17 years and for adults aged 18 - 70 years.
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K Number
K082255Device Name
QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT
Manufacturer
BODYSTAT LTD.
Date Cleared
2011-02-07
(913 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
BODYSTAT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the purposes of performing non-invasive bio-electrical impedance analysis (BIA) measurements on healthy human adults and children to determine their Body Composition status. Such measurements include Body Mass Index (BMI), waist/hip ratio, and tissue Impedance at 5, 50, 100 and 200 kHz. These measurements are used to calculate the estimated levels of extra-cellular water, intracellular water, total body water, body fat, body lean and dry lean, and metabolic rates. QuadScan 4000 for Windows Software Program is automatically included with the device.
Device Description
The OuadScan 4000 Body Composition & Fluid Monitoring Unit is a light weight, handheld, battery operated device that uses bio-electrical impedance analysis (BIA) to measure the impedance of the flow of an electrical current through the body; impedance is measured at four frequencies: 5, 50, 100, and 200 kHz. The impedance of tissue is proportional to the amount of fluid in the tissue: water is low in fat tissues, thus fat tissue has a high impedance, and lean tissue is high in water, thus lean tissue has a low impedance. The subject's age, sex, height, weight, waist measurement, and hip measurement are also used to calculate various values. In practice, a small constant current is passed between electrodes spanning the body and the voltage drop between electrodes provides a measure of impedance. Prediction equations, previously generated by correlating impedance measures against an independent estimate of TBW (total body water) and ECW (extra-cellular water), may be used subsequently to convert measured impedances to corresponding estimates of TBW and ECW. By deduction, ICW is estimated. By applying the unique Bodystat® equation, Body Fat, Lean Mass and Dry Lean Mass can be assessed. The QuadScan 4000 contains separate body composition equations for children 6 years to 17 years, and adults 18 - 70 years.
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K Number
K082253Device Name
BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT
Manufacturer
BODYSTAT LTD.
Date Cleared
2008-11-25
(109 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
BODYSTAT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the purposes of performing a non-invasive bio-impedance analysis (BIA) measurements on normal healthy human adults to determine their Body Composition status.
This device measures bio-electrical impedance when a 50 kHz signal is applied at specific locations on the subject. From this and the subject's age, gender, weight, height, waist and hip circumferences (optional), the device calculates the following estimated values: fat%, fat weight, lean%, lean weight, total body water%, total body water, dry lean weight, basal metabolic rate, basal metabolic rate/body weight ratio, average requirement (EAR), and actual body mass index and waist/hip ratio.
OPTIONAL ACCESSORIES: Bodystat (1) BODY MANAGER and (2) WELLNESS SOFTWARE PROGRAMS.
The Body Manager Program is ideal when a client returns to be tested in order to track their changes in body composition over a period of time.
The Wellness Program is ideal for first time assessments on subjects. The program's graphical presentations provide information on each of the specific measurements in an educational format.
Device Description
The Bodystat 1500 Body Composition Monitoring Unit is an impedance plethysmograph that uses bio-electrical impedance analysis (BIA) to measure the impedance of the flow of an electrical current through the body. The impedance of tissue is proportional to the amount of fluid in the tissue; water is low in fat tissues, thus fat tissue has a high impedance, and high in lean tissues, thus lean tissue has a high impedance.
In practice, a small constant current is passed between electrodes spanning the body and the voltage drop between electrodes provides a measure of impedance. Prediction equations, previously generated by correlating impedance measures against an independent estimate of TBW (total body water), may be used subsequently to convert a measured impedance to a corresponding estimate of TB W. Lean body mass is then calculated from this estimate using an assumed hydration fraction for lean tissue; Bodystat uses a proprietary regression equation for this calculation. Fat mass is calculated as the difference between body weight and lean body mass.
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K Number
K002835Device Name
BODYSTAT
Manufacturer
BODYSTAT LTD.
Date Cleared
2001-07-03
(294 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
BODYSTAT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994242Device Name
BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
Manufacturer
BODYSTAT LTD.
Date Cleared
2000-03-15
(90 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
BODYSTAT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MEASUREMENT OF:
ESTIMATED: Body FAT
BODY LEAN+
DRY LEAN
TOTAL BODY WATER
METABOLIC RATES
ACTUAL: BODY MASS INDEX (BMI)
WAIST / HIP RATIO
IMPEDANCE AT 50 kHZ
Device Description
Not Found
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K Number
K980971Device Name
BODYSTAT DUALSCAN 2005
Manufacturer
BODYSTAT LTD.
Date Cleared
1998-06-11
(87 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
BODYSTAT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ESTIMATED MEASUREMENT OF: FAT, LEAN, WATER, INTRA-CELLULAR WATER, EXTRA-CELLULAR WATER, TOTAL ESTIMATED WATER AND IMPEDANCE VALUES AT 50 KHZ
Device Description
Not Found
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K Number
K971554Device Name
BODYSTAT
Manufacturer
BODYSTAT LTD.
Date Cleared
1997-11-26
(210 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
BODYSTAT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MEASUREMENT OF ESTIMATED EXTRA-CELLULAR WATER; ESTIMATED INTRA-CELLULAR WATER. ESTIMATED TOTAL BODY WATER; AND
Device Description
Not Found
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