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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, extracellular fluid, lymphedema, extremity
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)
Product CodeOBH
Regulation Number 870.2770
Device Class 2


Premarket Reviews
ManufacturerDecision
DELFIN TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
DELFIN TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMPEDIMED LIMITED
  SUBSTANTIALLY EQUIVALENT 5

Recalls
Manufacturer Recall Class Date Posted
1 Impedimed Limited II Oct-24-2023
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