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510(k) K253224

MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) by ImpediMed Limited — Product Code OBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2026
Date Received
September 29, 2025
Clearance Type
Traditional
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

  • K232089 — SOZO Pro (October 17, 2023)
  • K230531 — SOZO Pro (May 4, 2023)
  • K230530 — 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

  • K230530 — SOZO Pro (May 4, 2023)
  • 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)