| Device |
monitor, extracellular fluid, lymphedema, extremity |
| Regulation Description |
Impedance plethysmograph. |
| Definition |
Measure impedances in affected and unaffected but opposite extremity to periodically monitor the level of extracellular fluid or the differences in bioimpedance between opposing extremities for patients who have been previously diagnosed with unilateral lymphedema (that is, in one affected extremity) |
| Physical State |
Electronic black box/monitor with keypad or other interface and display having the ability to connect to four electrodes and computer |
| Technical Method |
Applies a small alternating current of one or more frequencies through electrodes attached to particular locations on the skin surface of the subject's body and then measures/calculates level of bioimpedance indicated by living tissue over the area assessed |
| Target Area |
The arms and/or legs of the subject |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | OBH |
|---|
| 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 |
Not Third Party Eligible |
