2 devices · 1 company · 2017 to 2018
Product code OBH: Monitor, Extracellular Fluid, Lymphedema, Extremity
2 devices under product code OBH, 2017 to 2018, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Monitor, Extracellular Fluid, Lymphedema, Extremity. 21 CFR 870.2770, Class II. 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) MAUDE held 1 adverse-event report against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
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| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| SOZOK180126 · 510(k) | ImpediMed Limited | Cardiovascular | database entry | |
| SOZOK172122 · 510(k) | ImpediMed Limited | Cardiovascular | database entry |
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