# Ultrasonic Body Composition Analyzer
> **Product code: OMV** · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2770
## Classification
- **FDA Product Code:** OMV
- **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:** Y
## Definition

Intended to measure thickness of a distinctive tissue layer.  Indicated to Calculate the local thickness of a type of tissue [fat, muscle, bone, etc.] at a single location, or at various locations  on the body and via algorithms, estimate the amount of local tissue or total body tissue, respectively.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OMV)
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