Definition: Intended To Measure Thickness Of A Distinctive Tissue Layer. Indicated To Calculate The Local Thickness Of A Type Of Tissue [fat, Muscle, Bone, Etc.] At A Single Location, Or At Various Locations On The Body And Via Algorithms, Estimate The Amount Of
| Device Type ID | 1671 |
| Device Name | Ultrasonic Body Composition Analyzer |
| Physical State | Hand-held Cylindrical (or Other Shaped) Electro/mechanical Software-controlled Device Made Of Plastic And/or Metal Components And Crystalline Transducers. |
| Technical Method | Sends Ultrasonic Radiation Produced By A Piezoelectric Crystal Transmitter/transducer Through Body Tissue At The Site Chosen And Measures The Speed Of Reflection At A Piezoelectric Receiver/transducer. |
| Target Area | Any External Location On The Skin Or Designated Locations On The Arm, Leg, Abdomen, Chest, Etc. That Are Required To Validate The Body Composition Algorithm Used. |
| Regulation Description | Impedance Plethysmograph. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.2770 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OMV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1671 |
| Device | Ultrasonic Body Composition Analyzer |
| Product Code | OMV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Impedance Plethysmograph. |
| CFR Regulation Number | 870.2770 [🔎] |