Device Dossier

Body Composition Analyser - Body fat/lean ratio analyser

Device Dossier for Body Composition Analyser - Body fat/lean ratio analyser (Body fat/lean ratio analyser, Class IIa, sponsor ImpediMed). ARTG record,…

Intended purpose

Body Composition Analysis to estimate fat free mass (FFM) and fat mass (FM) and fluid distribution total body water (TBW) intracellular fluid (ICF) and extracellular fluid (ECF).

Functional description

The device is designed to measure body impedance and via software to convert the impedance values to measurements of body fluids (e.g. intracellular fluid and extra cellular fluid) and body composition values (e.g. fat free mass and fat mass).

TGA Public Summary