DSB · Plethysmograph, Impedance
Cardiovascular · 21 CFR 870.2770 · Class 2
Overview
| Product Code | DSB |
|---|---|
| Device Name | Plethysmograph, Impedance |
| Regulation | 21 CFR 870.2770 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 (20 of 114)
Showing 20 most recent of 114 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250634 | BCM2-Body Composition Monitor | Fresenius Medical Care Renal Therapies Group, LLC | Nov 24, 2025 | SESE |
| K243727 | Re:Balans | Mode Sensors AS | Oct 16, 2025 | SESE |
| K250922 | Edema Guard Monitor (EGM) CardioSet-001 | Cardioset Medical , Ltd. | Sep 9, 2025 | SESE |
| K232089 | SOZO Pro | ImpediMed Limited | Oct 17, 2023 | SESE |
| K223217 | Zynex Monitoring System, Model CM-1600 | Zynex Medical, Inc. | Jun 16, 2023 | SESE |
| K211585 | Bodyport Cardiac Scale | Bodyport, Inc. | Jul 29, 2022 | SESE |
| K203473 | SOZO | ImpediMed Limited | Apr 19, 2021 | SESE |
| K193410 | SOZO Body Fluid Analyzer | ImpediMed Limited | Oct 2, 2020 | SESE |
| K191697 | Cardiac Monitor 1500 | Zynex Medical, Inc. | Feb 21, 2020 | SESE |
| K180479 | ReDS System | Sensible Medical Innovations , Ltd. | Feb 28, 2019 | SESE |
| K172431 | Cardiovascular Analzyer | Physiowave, Inc. | Mar 14, 2018 | SESE |
| K172507 | SOZO | ImpediMed Limited | Dec 22, 2017 | SESE |
| K172196 | ECOM Cardiac Output Monitoring System | Ecom Medical, Inc. | Sep 19, 2017 | SESE |
| K150095 | ReDs Wearable System | Sensible Medical Innovations , Ltd. | Aug 6, 2015 | SESE |
| K142503 | IMED-Z FLUID STATUS MONITOR | Intersection Medical, Inc. | Jun 5, 2015 | SESE |
| K140102 | PHYSIOFLOW Q-LINK | Vasocom, Inc. | Feb 12, 2014 | SESE |
| K133301 | ZOE FLUID STATUS MONITOR | Noninvasive Medical Technologies, Inc. | Jan 22, 2014 | SESE |
| K131765 | ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM | Conmed Corporation | Dec 20, 2013 | SESE |
| K131509 | ZOE FLUID STATUS MONITOR | Noninvasive Medical Technologies, Inc. | Jun 28, 2013 | SESE |
| K112830 | ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) | Noninvasive Medical Technologies, Inc. | Nov 13, 2012 | SESE |
Top Applicants
- Cardiodynamics International Corp. — 11 clearances
- Bomed Medical Mfr., Ltd. — 4 clearances
- ImpediMed Limited — 4 clearances
- Biodynamics Corp. — 3 clearances
- Cardio Kinetics, Inc. — 3 clearances
