FDA Product Code OBH: Monitor, Extracellular Fluid, Lymphedema, Extremity
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)
Leading manufacturers include ImpediMed Limited and Delfin Technologies, Ltd..
FDA 510(k) Cleared Monitor, Extracellular Fluid, Lymphedema, Extremity Devices (Product Code OBH)
About Product Code OBH - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code OBH since 2007, with 10 receiving FDA clearance (average review time: 242 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under OBH have taken an average of 121 days to reach a decision - down from 256 days historically, suggesting improved FDA processing for this classification.
OBH devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →