OBH · Monitor, Extracellular Fluid, Lymphedema, Extremity
Cardiovascular · 21 CFR 870.2770 · Class 2
Overview
| Product Code | OBH |
|---|---|
| Device Name | Monitor, Extracellular Fluid, Lymphedema, Extremity |
| Regulation | 21 CFR 870.2770 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
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 | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) | ImpediMed Limited | Jan 28, 2026 | SESE |
| K230530 | SOZO Pro | ImpediMed Limited | May 4, 2023 | SESE |
| K220557 | MoistureMeterD Compact, LymphScanner | Delfin Technologies, Ltd. | May 27, 2022 | SESE |
| K180126 | SOZO | ImpediMed Limited | Apr 16, 2018 | SESE |
| K172122 | SOZO | ImpediMed Limited | Aug 11, 2017 | SESE |
| K143310 | MoisturemeterD | Delfin Technologies, Ltd. | Nov 19, 2015 | SESE |
| K130338 | IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS | ImpediMed Limited | May 31, 2013 | SESE |
| K100811 | IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 | ImpediMed Limited | Nov 4, 2011 | SESE |
| K080825 | IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 | Impedimed Pty , Ltd. | Oct 3, 2008 | SESK |
| K050415 | 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
