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The SOZO Pro has the following uses: For adult human patients at risk of lymphedema: A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of lymphedema. The use of the device to obtain an L-Dex score is only indicated for patients who will have or who have had lymph nodes, from the axillary and/or pelvic regions, either removed, damaged or irradiated. The SOZO Pro is intended for adult patients living with heart failure. This device is intended for use, under the direction of a physician, for the monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data. The SOZO Pro may be used as an adjunct to existing methods by aiding clinicians who are using Subjective Global Assessment (SGA) tools to assess patients at risk of protein-calorie malnutrition (PCM). The SOZO Pro may be further used to estimate the following body composition parameters in humans to track clinically relevant body composition parameters over time: - Fat mass - Fat-free mass - Total body water - Intracellular fluid - Extracellular fluid - Skeletal muscle mass - The following outputs are also presented: - Body Mass Index (BMI) - Basal metabolic rate (BMR; based on Mifflin St. Jeor's algorithm) displayed in calories per day - Protein and mineral (also known as 'dry lean mass') represents the content of a body that is not fat or fluid; calculated by subtracting total body water weight from fat-free mass weight. The SOZO Pro device measures current (I), voltage (V) and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are used to estimate the above body composition parameters. The device' software will also display the Cole plot, subject height, weight, age and sex.

The SOZO Pro system consists of a connected hand and footplate with built-in stainless-steel electrodes, paired with an Android tablet over Bluetooth connection. An app ("SOZOapp"), supplied with the tablet, controls the functionality of the hardware, and supplies the bioimpedance measurement data to a database ("MySOZO") managed on an external cloud- hosted database. Patient weight is measured with load cells located in the SOZO Pro foot unit or can be hand entered. Bioimpedance measurements require the patient's weight to be measured by a scale embedded in the base of the system or for the weight of the patient to be entered manually. Following the collection of the patient weight, the patient contacts the SOZO Pro with their bare hands and feet on stainless steel electrodes. The impedance measurement takes about 30 seconds, during which the SOZO Pro® system applies small levels of electrical energy (200μA RMS) to the body across 256 frequencies spaced from 3kHz to 1000kHz and measures the resulting voltage levels.

Monitoring of the following parameters and their relative of relative of relative changes in fluid volume in adult patients: - Bioelectrical Impedance - ECG Amplitude - PPG Amplitude - Skin Temperature

The Zynex Monitoring System, Model CM-1600, simultaneously monitors various parameters of a patient's body. These parameters include Bioelectrical Impedance, Electrocardiogram (ECG) Amplitude, Photoplethysmography (PPG) Amplitude, and Skin Temperature. A Relative Index value is calculated as a combination of the changes in these parameters and is represented by a single number. The CM-1600 System is comprised of two (2) subsystems, the Wearable and the Monitor. The CM-1600 Wearable is designed and developed by Zynex Monitoring Solutions, and it collects physiological parameters and transmits those parameters to the CM-1600 Monitor via wireless communication. The CM-1600 Monitor is a Zynex-branded, third-party all-in-one medical grade tablet.

The Bodyport Cardiac Scale is intended for use, under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management related health conditions. The device is intended to be used to measure and track body weight, peripheral impedance, pulse rate, and center of pressure. The device is intended to be used in the home or clinic environment. Intended users are people over 21 years of age who can stand for the measurement and weigh less than 180 kg (397 lbs). The device does not generate any real-time alarms for consideration by the user at home or by a healthcare professional. Data from the device should be used in the context of all clinical data to make determinations of a patient's status.

The Bodyport Cardiac Scale is a non-invasive cardiovascular monitor and body weight scale that measures body weight, peripheral impedance, pulse rate, and center of pressure through the feet of a user standing on its surface. The device is powered by four (4) AA alkaline batteries. The device is comprised of a physical platform on which the user stands with bare feet. Four electrodes located on the top surface of the platform are used to measure of the user's lower body (foot-to-foot). The impedance signal is obtained by applying a small, safe battery-generated current (<500uA) between the feet of the user and measuring the resulting electrical potential. The impedance signal reflects the electrical resistance of the lower body and is modulated by changes in fluid levels and blood flow in the lower part of the body, enabling the calculation of parameters such as pulse rate and peripheral impedance. The impedance signal is captured at two frequencies (8kHz) to enable the calculation of peripheral impedance values that reflect intra- and extra-cellular fluid levels. The 64kHz signal is used to calculate impedance magnitude and phase angle to measure pulse rate. Additionally, load cells in each of the four corners of the device measure the static and dynamic loads being applied to the device by the user's body. The load cells are used to measure the user's body weight and center of pressure. The device may show body weight, peripheral impedance, and pulse rate information on a display integrated into the platform. A user is instructed to stand on the Bodyport Cardiac Scale with bare feet. The measurement starts automatically when the user steps on the scale. The device acquires the data and notifies the user that the measurement is complete through a gentle haptic vibration and displays the results on the device screen. Data collected by the Bodyport Cardiac Scale is automatically transmitted via cellular communication to the Bodyport cloud where it can be accessed through a supported web-based browser, dashboard or API.

The SOZO Body Fluid Analyzer is intended for adult patients living with heart failure. This device is intended for use, under the direction of a physician, for the noninvasive monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data.

The SOZO system consists of a connected hand and footplate with built-in stainless steel electrodes, paired with an Android tablet over Bluetooth connection. An app ("SOZOapp"), supplied with the tablet, controls the functionality of the hardware and supplies the bioimpedance measurement data to a database ("MySOZO") managed on an external cloudhosted database. Measurements require the patient to make contact with bare hands and feet on stainless steel electrodes. The measurement takes about 30 seconds, during which the SOZO® system applies small levels of electrical energy (200uA RMS) to the body across 256 frequencies spaced from 3kHz to 1000kHz and measures the resulting voltage levels.

The SOZO Body Fluid Analyzer is intended for adult patients living with heart failure. This device is intended for use, under the direction of a physician, for the noninvasive monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data.

The SOZO system consists of a connected hand and footplate with built-in stainless steel electrodes, paired with an Android tablet over Bluetooth connection. An app ("SOZOapp"), supplied with the tablet, controls the functionality of the hardware and supplies the bioimpedance measurement data to a database ("MySOZO") managed on an external cloudhosted database. Measurements require the patient to make contact with bare hands and feet on stainless steel electrodes. The measurement takes about 30 seconds, during which the SOZO™ system applies small levels of electrical energy (200µA RMS) to the body across 256 frequencies spaced logarithmically from 3kHz to 1000kHz and measures the resulting voltage levels.

Monitoring of the following parameters and their relative changes, indicative of relative changes in fluid volume in adult patients. - Bioelectrical Impedance - Heart Rate - ECG Amplitude - PPG Amplitude

Cardiac Monitor, Model 1500 and accessories monitor a patient's parameters. These parameters include: Bioelectrical Impedance, Heart Rate, ECG Amplitude, and Skin Temperature. The Cardiac Monitor, Model 1500, is intended to be used in a professional medical environment such as hospitals, clinics and research institutions. The Cardiac Monitor, Model 1500, is a standalone device intended for desktop use. Measurements are to be performed under uninterrupted patient surveillance by the operator. The user of the Cardiac Monitor, Model 1500, shall be a qualified operator. The operator shall have knowledge of the system and data interpretation, obtained via medical education, system manuals and/or specific courses. The device does not report any diagnosis but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers.

The ReDS System is intended for use by qualified healthcare practitioners, under the direction of a physician, in hospitals, hospital-type facilities and home environments, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications. The ReDS System is indicated for patients: - With fluid management problems - Taking diuretic medication - Living with heart failure - Recovering from a coronary artery disease-related event

The ReDS System ("ReDS" or "ReDS System") is a non-invasive thoracic base wave impedance monitor that provides measurement of patient lung fluid content. ReDS™ technology measures wave impedance of biological tissues. Low power electromagnetic (EM) signals are emitted into the body, and intercepted by sensors on the body. The wave impedance is a function of the distributed tissue conductivity and capacitance properties, and is representative of tissue fluid content. The system consists of a Sensor Unit connected to a bedside console, as well as a cloud application. The Sensor Unit encases two sensors and an attachment mechanism. The Bedside Console is an enclosure housing the electronic modules, an embedded computer and a touch-screen display. The device software provides the management of the device as well as analysis of the measured signals, graphic display of readings, reporting, and communications functionality to enable remote patient monitoring.

The Cardiovascular Analyzer is intended to obtain Pulse Wave Velocity (PWV) and Pulse Rate (PR) through a combination of impedance plethysmography and weight measurements in adults 18 years of age and older. The Cardiovascular Analyzer also measures Body Weight and calculates BMI.

The Cardiovascular Analyzer is designed to perform non-invasive physiologic measurements for PWV, PR, and BW, and to calculate BMI. The Cardiovascular Analyzer uses strain gauge sensors to measure BW and the ballistocardiogram (BCG). The BCG provides an indication of the arterial pulsation in the aortic arch. The Cardiovascular Analyzer also uses impedance plethysmography (IPG) sensing to estimate the PR and arterial pulsation in the legs. PWV is then calculated using the subject's sternal height (measured with a height rod) and the Pulse Transit Time (PTT) derived from the BCG and IPG signals. The Cardiovascular Analyzer is comprised of the following key components and accessories: Scale Platform, Console, USB Cable, Isolated Power Supply and Power Cord, Height Rod, Visual Guide Accessory and Console Wall Mount. The device uses two sensing modalities (load cells and impedance electrodes) to perform the following three measurements: PWV, PR and BW. BMI is calculated using BW and the operator-entered subject's overall height measurement.

The SOZO Fluid Status Monitor is intended for adult patients living with heart failure. This device is intended for use, under the direction of a physician, for the noninvasive monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data.

The SOZO™ system consists of a connected hand and footplate with built-in stainless steel electrodes, paired with an Android tablet over Bluetooth connection. An app ("SOZOapp"), supplied with the tablet, controls the functionality of the hardware and supplies the bioimpedance measurement data to a database ("SOZOhub") contained within the hospital/facility network. Measurements require the patient to make contact with bare hands and feet on stainless steel electrodes. The measurement takes about 30 seconds, during which the SOZO™ system measures small quantities of electrical energy (200uA RMS) across 256 frequencies, spaced logarithmically from 3kHz to 1000kHz. Established algorithms are used to analyze data and calculate extracellular fluid impedance levels for left and right sides of the body, and present the impedance levels for the clinician to review. These scores facilitate the clinician's monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.

The ECOM Cardiac Output Monitoring System is intended for the monitoring of cardiac output by impedance cardiography. The ECOM System displays the R-Wave Detection and the Impedance Waveforms as well as the patient's Cardiac Output (CO), Stroke Volume (SV), Heart Rate (HR), Systolic and Diastolic Pressure. The ECOM System is indicated for use in patients who are expected to be intubated for 24 hours or less and in whom an arterial pressure line is used. The ECOM with the endotracheal cardiac output monitor system is intended for the monitoring of cardiac output by impedance cardiography while providing airway management by oral intubation with an ECOM endotracheal tube. The ECOM Double Lumen Endobronchial Tube is used to isolate the left lung of a patient for surgery, one lung ventilation or one lung anesthesia. The ECOM Endobronchial Tube is indicated for use in thoracic surgery, bronchspirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes. The tube allows isolation and selective insufflation or deflation of either lung.

The ECOM Cardiac Output Monitor System consists of a monitor, and various accessories. The line extension of the ECOM Double Lumen Endobronchial Tube to the systems line of Endotrachel tubes continues to apply a high frequency. low amplitude electrical current to a series of electrodes applied to the endobronchial tube. The resulting signals, when used in conjunction with an arterial pressure signal, allow for the calculation and display of Cardiac Output (CO), Cardiac Input (CI), Stroke Volume (SV), Stroke Volume Variation (SVV), Heart Rate (HR), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI), and systolic, diastolic and mean blood pressures. No changes have been made to the monitor system in K131765 or the endobronchial tube design in K092886.