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) → OBH — Monitor, Extracellular Fluid, Lymphedema, Extremity

# OBH · Monitor, Extracellular Fluid, Lymphedema, Extremity

_Cardiovascular · 21 CFR 870.2770 · Class 2_

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

## Overview

- **Product Code:** OBH
- **Device Name:** Monitor, Extracellular Fluid, Lymphedema, Extremity
- **Regulation:** [21 CFR 870.2770](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2770)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## 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 (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253224](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/OBH/K253224.md) | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) | ImpediMed Limited | Jan 28, 2026 | SESE |
| [K230530](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/OBH/K230530.md) | SOZO Pro | ImpediMed Limited | May 4, 2023 | SESE |
| [K220557](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/OBH/K220557.md) | MoistureMeterD Compact, LymphScanner | Delfin Technologies, Ltd. | May 27, 2022 | SESE |
| [K180126](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/OBH/K180126.md) | SOZO | ImpediMed Limited | Apr 16, 2018 | SESE |
| [K172122](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/OBH/K172122.md) | SOZO | ImpediMed Limited | Aug 11, 2017 | SESE |
| [K143310](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/OBH/K143310.md) | MoisturemeterD | Delfin Technologies, Ltd. | Nov 19, 2015 | SESE |
| [K130338](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/OBH/K130338.md) | IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS | ImpediMed Limited | May 31, 2013 | SESE |
| [K100811](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/OBH/K100811.md) | IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 | ImpediMed Limited | Nov 4, 2011 | SESE |
| [K080825](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/OBH/K080825.md) | IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 | Impedimed Pty , Ltd. | Oct 3, 2008 | SESK |
| [K050415](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/OBH/K050415.md) | IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS | Impedimed Pty , Ltd. | Mar 30, 2007 | SESK |

## Top Applicants

- ImpediMed Limited — 6 clearances
- Delfin Technologies, Ltd. — 2 clearances
- Impedimed Pty , Ltd. — 2 clearances

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

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