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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
Regulation Description Impedance plethysmograph.
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

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