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510(k) Data Aggregation
K Number
K060552Device Name
BC100 BODY COMPOSITION ANALYSIS SYSTEM
Manufacturer
Date Cleared
2006-05-24
(83 days)
Product Code
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
ATHLETIC IQ, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BC100 Body Composition Analysis System is a noninvasive bioimpedance analyzer for use in healthy subjects for measurement of actual height, actual weight and estimated body fat percentage. The applicable age range is 10 to 80 years old.
Device Description
The proposed Athletic IQ, Inc. (AIQ) BC100 Body Composition Analysis System is a noninvasive bioimpedance analyzer for use in healthy subjects for measurement of actual height, actual weight and estimated body fat percentage. The applicable age range is 10 to 80 years old. The device determines estimated body fat percentage based on bioelectrical impedance analysis (BIA). BIA relies on the differing behavior of biological tissues in response to an applied electrical current. Lean tissue is generally highly conductive, whereas fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA permits differentiation of fat vs. lean tissue. When combined with the subject's height and weight parameters, age, and gender, an estimated body fat percentage may be calculated using an experimentally derived algorithm.
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