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U.S. Department of Health and Human Services

Product Classification

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Device plethysmograph, air displacement for body composition analysis
Regulation Description Impedance plethysmograph.
Definition To measure the total body volume and weight for calculating the estimated body composition (total body fat and total body lean mass).
Physical State An air-tight, dual compartment fiberglass and plexiglas chamber that the subject enters
Technical Method Uses Boyle's law in conjunction with the two precisely-sized compartments to determine the volume occupied by the subject's body. Average total body density is calculated from the weight and volume determined by the device. Empirical equations, as a function of density of known tissue types, are then used to estimate body composition parameters.
Target Area whole body
Regulation Medical Specialty Cardiovascular
Review Panel Obstetrics/Gynecology
Product CodeOAC
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 870.2770
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons