OBH

Monitor, Extracellular Fluid, Lymphedema, Extremity

Product code

OBH

Device name

Monitor, Extracellular Fluid, Lymphedema, Extremity

Device class

Class 2

21 CFR

21 CFR 870.2770

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

10 (all years; only the last 3 years are listed here)

FDA classification 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)

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-01-28.

1 summaries are archived here for direct download.