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U.S. Department of Health and Human Services

Product Classification

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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)
Physical State Electronic black box/monitor with keypad or other interface and display having the ability to connect to four electrodes and computer
Technical Method Applies a small alternating current of one or more frequencies through electrodes attached to particular locations on the skin surface of the subject's body and then measures/calculates level of bioimpedance indicated by living tissue over the area assessed
Target Area The arms and/or legs of the subject
Regulation Medical Specialty Cardiovascular
Review Panel Gastroenterology/Urology
Product CodeOBH
Premarket Review Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 870.2770
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible