| 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 Code | OAC |
|---|
| 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
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
|
Third Party Review
|
Accredited Persons
|
