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 Unilate
| Device Type ID | 1670 |
| Device Name | Monitor, Extracellular Fluid, Lymphedema, 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 A |
| Target Area | The Arms And/or Legs Of The Subject |
| 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 | OBH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1670 |
| Device | Monitor, Extracellular Fluid, Lymphedema, Extremity |
| Product Code | OBH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Impedance Plethysmograph. |
| CFR Regulation Number | 870.2770 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DELFIN TECHNOLOGIES LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IMPEDIMED LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |