Product code OBH

Device name
Monitor, Extracellular Fluid, Lymphedema, Extremity
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.2770
Review panel
GU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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)
Source
FDA openFDA device classification dataset