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510(k) Data Aggregation
K Number
K100183Device Name
MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER
Manufacturer
Date Cleared
2011-04-15
(449 days)
Product Code
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
TANITA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Tanita Body Composition Analyzer is indicated for use in the measurement of weight and impedance, and the estimation of body mass index (BMI), total body and segmental fat percent and weight, total body water percent and weight, intracellular and extracellular water weight, total body and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), and fat free mass (FFM), using BIA (Bioelectrical Impedance Analysis).
The device is indicated for use for healthy children 5–17 years old and healthy adults with active, moderately active, to inactive lifestyles.
For subjects 17 years old and younger, only fat % is displayed.
Device Description
The Tanita Model MC-180MA Multi-frequency Body Composition Analyzer is a computer-operated body composition analyzer that utilizes bioelectrical impedance analysis (BIA) to estimate body composition of fat, muscle and bone, water compartments, and basal metabolic rate (BMR).
Actual measurements made by the MC-180MA include body weight and bioelectrical impedance. BIA is used to make estimates based upon these measured values.
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K Number
K040778Device Name
TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)
Manufacturer
Date Cleared
2004-12-23
(272 days)
Product Code
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
TANITA CORP. OF AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TANITA family of InnerScan Body Composition Monitors measure body weight and impedance and estimate percentage of body fat and body water, visceral fat rating, bone mass, muscle mass, physique rating, daily calorie intake (DCI) and metabolic age using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 7-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.
Device Description
The TANITA InnerScan Body Composition Monitor is a computer-operated body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat percent, body water percent, muscle mass, bone mass, visceral fat rating, metabolic age, physique rating and daily calorie intake.
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K Number
K040978Device Name
TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE
Manufacturer
Date Cleared
2004-07-22
(98 days)
Product Code
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
TANITA CORP. OF AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A body composition analyzer that measures body weight and impedance and estimates percentage of body fat and body water using BIA (bioelectrical impedance analysis) in healthy children (7-17 years old) and healthy adults.
Device Description
The TANITA Scale plus Body Fat Monitor with Body Water Percentage is a computeroperated body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat and body water percentage.
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K Number
K033157Device Name
TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418
Manufacturer
Date Cleared
2004-04-08
(191 days)
Product Code
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
TANITA CORP. OF AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A body composition analyzer that measures body weight and impedance and estimates total and segmental body fat percent, body mass index (BMI), fat mass, fat-free mass, regional muscle mass, basal metabolic rate, and total body water using BIA (bioelectrical impedance analysis) in healthy children (7-17 years old) and healthy adults.
Device Description
The TANITA BC-418, Segmental Body Composition Analyzer is a computer-operated body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat percent and regional muscle mass.
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K Number
K014009Device Name
TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE
Manufacturer
Date Cleared
2002-06-24
(201 days)
Product Code
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
TANITA CORP. OF AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MODELS TBF-300A, TBF-310, TBF-410, TBF-215, BF-350: A body composition analyzer that measures body weight and impedance and estimates body fat percent. BMI, fat mass, fat free mass, basal metabolic rate, and total body water using BIA (bioelectrical impedance analysis). MODELS TBF-611, TBF-612, TBF-621, TBF-622, BF-623, BF-625, BF-626, BF-541, BF-555, BF-542, TBF-551, BF-556, BF-558, BF-559, BF-572, TBF-521, Ultimate Scale 2001: A body composition analyzer that measures body weight and impedance and estimates body fat percent using BIA (bioelectrical impedance analysis).
Device Description
The TANITA Body Fat Monitor/Scales (multiple models) are designed to determine body weight and body fat composition. Each model will offer a range of features. The system consists of two subdivided stainless steel footpad electrodes mounted on a platform scale. The four-foot electrodes are designed where each foot makes contact with a heel and toe electrode. Impedance of the lower extremities and body weight is measured simultaneously while the subject stands on the scale.
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