DeviceClearance

Product code OBH— Cardiovascular

SOZO

Classification name
Monitor, Extracellular Fluid, Lymphedema, Extremity
Device class
Class 2
Regulation
21 CFR 870.2770
Advisory panel
Cardiovascular
Total cleared
10
First cleared
Most recent

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)”

— U.S. Food and Drug Administration, device classification record for product code OBH under 21 CFR 870.2770, via openFDA

Market context for product code OBH

FDA has cleared 10 devices under product code OBH between 2007 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OBH

Recent clearances under product code OBH

Data sourced from openFDA. This site is unofficial and independent of the FDA.