Skip to content

Parker Quality & Compliance

PQC Reg Watch

Sponsor this week — one slot, $75, newsletter line and this bar

Device type

Monitor, Extracellular Fluid, Lymphedema, Extremity

Product code OBH · Class II · 21 CFR 870.2770 · Cardiovascular

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)

FDA classification database

Recent 510(k)s

Recent recalls

No recalls in the archive for OBH.