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510(k) Data Aggregation
K Number
K023817Device Name
SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010
Manufacturer
Date Cleared
2003-06-25
(222 days)
Product Code
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
CLIO DESIGNS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SmartShape Body Composition Analyzer is a noninvasive bioimpedance analyzer intended for use in the estimation of percent body fat by body weight.
Device Description
The SmartShape Body Composition Analyzer is a hand-held device designed to determine body fat composition. The device offers the user the ability to measure their body fat level and store the data for analvsis. It is programmable for up to 10 separate individuals and uses bioelectric impedance technology for the estimation of percent body fat. The device also includes a clock and alarm function.
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