# Monitor, Extracellular Fluid, Lymphedema, Extremity
> **Product code: OBH** · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2770
## Classification
- **FDA Product Code:** OBH
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 870.2770
- **Review panel:** GU
- **Medical specialty:** Cardiovascular
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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)

## Market data
- **Cleared 510(k) submissions:** 10
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OBH)
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