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510(k) Data Aggregation
K Number
K060538Device Name
BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563 AND 9568
Manufacturer
Date Cleared
2006-10-10
(224 days)
Product Code
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
BEAVERITE INTERNATIONAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Beaverite Body Fat Scales -- Models 8921, 8925, 8931, 8935 and 9576 -- measure body weight and impedance, and estimate percentages of body fat and total body water. They are intended for use by healthy adults.
The Beaverite Body Fat Scales -- Models 8919, 8923, 8929, 9580, 9583, and 9588 -- measure body weight and impedance, and estimate percentages of body fat, total body water, and total muscle mass. They are intended for use by healthy adults.
Device Description
The 11 models of Beaverite body fat scales submitted in this 510(k) are plethysmograph body composition analyzers. The devices estimate percentages of body fat, body water and muscle mass (as noted in the Indications statement) based on bioelectrical impedance analysis (BIA).
Body composition analyzer/scale that utilizes a 'foot-to-foot' bioelectrical impedance (BIA) technology to determine internal body composition.
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