| Device |
ultrasonic body composition analyzer |
| Regulation Description |
Impedance plethysmograph. |
| 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 local tissue or total body tissue, respectively. |
| 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 Medical Specialty |
Cardiovascular |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | OMV |
|---|
| Premarket Review |
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
| 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
|
