510(k) K230530

SOZO Pro by ImpediMed Limited — Product Code OBH

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 4, 2023
Date Received: February 27, 2023
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Monitor, Extracellular Fluid, Lymphedema, Extremity
Device Class: Class II
Regulation Number: 870.2770
Review Panel: GU
Submission Type

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)

Other clearances by ImpediMed Limited

K253224 — MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) (January 28, 2026)
K232089 — SOZO Pro (October 17, 2023)
K230531 — SOZO Pro (May 4, 2023)
K203473 — SOZO (April 19, 2021)
K193410 — SOZO Body Fluid Analyzer (October 2, 2020)
K190529 — SOZO (November 25, 2019)
K180126 — SOZO (April 16, 2018)
K172507 — SOZO (December 22, 2017)
K172122 — SOZO (August 11, 2017)
K130338 — IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS (May 31, 2013)

Other clearances for product code OBH

K253224 — MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) (January 28, 2026)
K220557 — MoistureMeterD Compact, LymphScanner (May 27, 2022)
K180126 — SOZO (April 16, 2018)
K172122 — SOZO (August 11, 2017)
K143310 — MoisturemeterD (November 19, 2015)
K130338 — IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS (May 31, 2013)
K100811 — IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 (November 4, 2011)
K080825 — IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 (October 3, 2008)
K050415 — IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS (March 30, 2007)