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510(k) Data Aggregation
K Number
K083838Device Name
SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES
Manufacturer
FOOK TIN TECHNOLOGIES LIMITED
Date Cleared
2009-05-12
(140 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
FOOK TIN TECHNOLOGIES LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Scaleman Body Fat Scales - Models in "Family Model List 1A" is a series of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.
The Scaleman Body Fat Scales - Models in "Family Model List 1B" is a series of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water, bone mass and muscle mass using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.
Device Description
Body composition analyzer/scale that utilizes a “foot-to-foot” bioelectrical impedance (BIA) technology to determine internal body composition.
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