Let's take a couple minutes to fully discuss and Understand Accuracy of the Balance Smart Scale.
SCALE ACCURACY:
Via harmless electrical current stimulation (500 pA at 50 kHz), the Balance Scale calculates body fat percentage (“BFP”) using the Bioelectrical Impedance Method. The current is passed through the body and electrical impedance is measured. Using this measurement, along with height, weight, age, and gender, BFP is calculated. As the calculation relies on the proper use of the scale and variables entered by the user, there are elements of this process that can produce erroneous readings, as described more fully in the troubleshooting section of this guide. Based on clinical testing submitted to the FDA, the Balance Scale is substantially equivalent to the Tanita® BC-533 (K040778) Scale and the DEXA Standard.
CLINICAL STUDY (& REGULATORY VALIDATION):
Clinical studies have validated that body composition measurements from the Balance Scale are substantially equivalent to an established in-market scale from Tanita®. This clinical outcome shows a positive and high correlation across all body composition measurements: body fat %, hydration %, lean mass and bone mass. The average variance in body fat % was 0.45%, and the correlation of
body fat % was very high at 0.994 (max value is 1.000).
Furthermore, this is based on a DEXA Standard. The Tanita® Scale was used as the comparative device for the clinical study above because Tanita®Scales have consistently shown positive and high correlations against the most accurate, industry-standard form of body composition analysis, the DEXA (dual-energy x-ray absorptiometry) scan. These correlations confirm the Balance Scale is also highly correlated with the DEXA standard.
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