Search Results
Found 2 results
510(k) Data Aggregation
K Number
K090479Device Name
TANITA BODY COMPOSITION ANALYZER, MODEL SC-331
Manufacturer
TANITA CORPORATION OF AMERICA
Date Cleared
2009-07-07
(133 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
TANITA CORPORATION OF AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 fat percent, total body water percent and weight, muscle mass (skeletal and smooth), physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass, 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.
Device Description
The TANITA Body Composition Analyzer SC-331 is a composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body mass index (BMI), total body fat percent, total body water percent and weight, muscle (skeletal and smooth), physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass for use by adults and children.
Ask a Question
K Number
K062652Device Name
INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR
Manufacturer
TANITA CORPORATION OF AMERICA
Date Cleared
2006-12-28
(112 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
TANITA CORPORATION OF AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TANITA Ironman Innerscan Body Composition Monitor measures body weight, impedance and estimates total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate(BMR), daily caloric intake(DCI) and metabolic age using BIA (Bioelectrical Impedance Analysis). The device is intended to be used by generally healthy children 7-17 years old and generally healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment. Actual measurements made by the BC-558 include weight and impedance. Based upon these measured values, values are calculated for: total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI) and metabolic age.
Device Description
The TANTA Ironman Innerscan Body Composition Monitor BC-558 are a computer-operated body composition analyzer that utilizes BlA (bigledrical impedance analysis) to determine body fat percent, muscle mass, bone weight, visceral fat rating, Basal Metabolic Rate (BMR), metabolism age, physique rating, daily calorie intake (DCI), body water percent and segmental fat percent.
Ask a Question
Page 1 of 1