Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2770](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2770) → OMV — Ultrasonic Body Composition Analyzer

# OMV · Ultrasonic Body Composition Analyzer

_Cardiovascular · 21 CFR 870.2770 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/OMV

## Overview

- **Product Code:** OMV
- **Device Name:** Ultrasonic Body Composition Analyzer
- **Regulation:** [21 CFR 870.2770](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2770)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.

## Classification Rationale

Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

## Special Controls

*Classification.* Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K082147](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/OMV/K082147.md) | BODYMETRIX BX2000 | Intelametrix, Inc. | Mar 20, 2009 | SESE |

## Top Applicants

- Intelametrix, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/OMV](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/OMV)

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