OBH · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2770
Classification
FDA Product Code
OBH
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.2770
Review panel
GU
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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)