Definition: To Measure The Total Body Volume And Weight For Calculating The Estimated Body Composition (total Body Fat And Total Body Lean Mass).
| Device Type ID | 3871 |
| Device Name | Plethysmograph, Air Displacement For Body Composition Analysis |
| 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 |
| Target Area | Whole Body |
| Regulation Description | Impedance Plethysmograph. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.2770 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OAC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3871 |
| Device | Plethysmograph, Air Displacement For Body Composition Analysis |
| Product Code | OAC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Impedance Plethysmograph. |
| CFR Regulation Number | 870.2770 [🔎] |