Monitor, Extracellular Fluid, Lymphedema, Extremity
Cardiovascular · 21 CFR 870.2770
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)
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
1 recall events for this product code
Registered firms
12 firms currently registered for this product code
510(k) clearances
10 clearances for this product code
- ImpediMed LimitedJan 28, 2026
K253224 · MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
- ImpediMed LimitedMay 4, 2023
K230530 · SOZO Pro
- Delfin Technologies, Ltd.May 27, 2022
K220557 · MoistureMeterD Compact, LymphScanner
- ImpediMed LimitedApr 16, 2018
K180126 · SOZO
- ImpediMed LimitedAug 11, 2017
K172122 · SOZO
- Delfin Technologies, Ltd.Nov 19, 2015
K143310 · MoisturemeterD
- ImpediMed LimitedMay 31, 2013
K130338 · IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS
- ImpediMed LimitedNov 4, 2011
K100811 · IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400