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The Withings ECG App is a software-only device intended for use with the ScanWatch to create, record, store, transfer and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The Withings ECG App determines the presence of atrial fibrillation (AFib), sinus rhythm and high heart rate (no signs of AFib with heart rate 100-150 bpm) on a classifiable waveform. The Withings ECG App is not recommended for users with other known arrhythmias. The Withings ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the Withings ECG App is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment. The Withings ECG App is intended to supplement rhythm classification for the purposes of discriminating AFib from normal rhythms. The device is not intended to replace traditional methods or diagnosis. The ECG acquired by ScanWatch is not intended for manual and/or automated measurement of QT-interval. The Withings ECG app is not intended for use by people under 22 years old.

The Withings ECG App is a software only mobile medical application that has two components: - Withings ECG Watch App - Withings ECG Phone App The Withings ECG Watch App is integrated on the Withings ScanWatch, model number hwa10. The Withings ECG Watch App analyzes the data collected by electrodes on the Withings ScanWatch to generate an ECG waveform similar to a Lead I, calculate the average heart rate and provide rhythm classification to the user for a given 30 second session. Withings ECG Watch App consists of a software library called ECG-SW2 library. The ECG-SW2, is a software library that includes an algorithm that processes the raw ECG signals and a tracing filter that filters the ECG signal to provide the user an output on the user interface (watch and smartphone). The Withings ECG Phone App contains the installation steps, tutorial and the instructions for use that the user must review prior to taking an ECG reading. The Withings ECG Phone App is included in the Withings App, which displays the ECG results and also allows the user to store, manage and share health data.

Withings Sleep Rx is indicated to record a patient's Withings index during sleep as an aid for diagnosis of obstructive sleep apnea (OSA). The Withings Sleep Rx is also indicated to record heart rate and movement in an automatic contactless manner. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required. The device is indicated for use in adults weighing ≤ 350 lbs in a home environment during sleep and resting conditions. This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations.

The Withings Sleep Rx is a device intended as an aid for diagnosis of obstructive sleep apnea (OSA). It is intended for home use. The device is placed under the mattress and is contactless with the user. It provides a Withings index based on breathing (sound, variations of pressure in the bladder) and heart rate measured in a contactless manner. The number of breathing events per hour is displayed to the user in the companion app. The results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. In addition, the device records heart rate and movement during sleep in an automatic contactless manner. The recordings are displayed in the companion app. Withings Sleep Rx is composed of the following components: (1) Mat (hardware); (2) Withings Sleep Rx embedded software included in the Mat and (3) Companion App included in a companion mobile application.

The Withings Scan Monitor 2.0 is intended to record, store and transfer lead II and lead-III of a twochannel electrocardiogram (ECG). In addition, it calculates and displays leads I, aVF, aVL. The Withings Scan Monitor 2.0 also displays ECG rhythms and detects the presence of atrial fibrillation (when the monitor is prescribed or used under care of a physician). The Withings Scan Monitor 2.0 is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. The Withings Scan Monitor 2.0 is intended for adult patients in hospitals, clinics, long-term care facilities, and homes.

The Withings Scan Monitor 2.0 is a connected smart scale with a retractable handle, with Bluetooth and Wi-Fi capabilities that connects to a companion mobile application. The Withings Scan Monitor 2.0 is intended to create, record, store, transfer and display lead-III of a two-channel electrocardiogram (ECG). When a user stands on the scale and holds the handle attached to it, a 30 second ECG recording begins. The Withings Scan Monitor 2.0 software analyzes data collected by the electrical sensors present on the scale to generate lead-III simultaneously and derive lead-I and leads aVR, aVF and aVL, calculate heart rate, and provide a rhythm classification to the user that is displayed on the scale. The companion application is intended to display, store, manage and share data. The Withings Scan Monitor 2.0 classifies ECG signals as follows: - Normal Sinus Rhythm - Atrial Fibrillation - Inconclusive - Noise - Inconclusive

The Scan Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Scan Monitor also displays ECG rhythms and detects the presence of atrial fibrillation (when the monitor is prescribed or used under the care of a physician). The Scan Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. The Scan Monitor is also indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2). The Scan Monitor is intended for spot-checking of adult patients in hospitals, clinics, long-term care facilities, and homes.

The Scan Monitor is a wearable, Bluetooth-connected wrist-worn watch that records two medical measurements-heart activity (electrocardiogram (ECG)) and oxygen saturation (SpO2)-as well as other measurements including step cycles, running, biking, and walking. The Scan Monitor has a companion mobile application called Health Mate. The Scan Monitor is available in two sizes, 38 mm and 42 mm, which have different watch faces but are otherwise identical. The Scan Monitor has two stainless steel electrodes integrated on the back case of the watch and are always in contact with the skin. One of these two electrodes is used to obtain a reference signal and reduce the noise on the ECG signal. A third electrode is accessible by the free hand (the hand that does not wear the device) on the top of the device. The Scan Monitor classifies ECG signals as follows: - 0 Normal Sinus Rhythm; - Atrial Fibrillation; . - . Inconclusive; - 0 Noisy. The SpO2 measurements are obtained by a photoplethysmograph sensor located at the backcase of the product. This sensor is composed of three LEDs (green, red, and infrared) and two photodiodes (one large band and one with a green filter). The Scan Monitor is validated for an SpO2 range of 70% to 100% and an SpO2 range between 85% to 100% is displayed on the gauge. All measurements obtained by the Scan Monitor are available in the companion Health Mate app.

The Withings Thermo (Model SCT01) is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch mode over the measurement site on people of all ages.

The Withings Thermo (Model SCT01) is a hand-held, battery powered device designed to measure human body temperature. The SCT01 device is an infrared thermometer that, when placed in contact with the user's skin over the temporal artery, measures the natural infrared energy emitted from the surface of the skin and convert it to an oral equivalent temperature. The Withings Thermo (Model SCT01) thermometer uses a thermopile sensor for the target reading, a thermistor-like pin junction for ambient temperature readings, and a silicon lens to focus the radiated energy on the thermopile sensor. It embeds a 20x5 LEDs matrix for display of results, and also a Wi-Fi/ Bluetooth module for optional usage of a smartphone application to log results

The Withings Blood Pressure Monitor, Upper Arm Type: BP-801 is noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to be 9 to 17 inches (22cm-42cm) for Upper Arm type.

The Withings BP-801 is a blood pressure monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 to 17 inches (22 - 42 cm) via an arm cuff. It is designed and manufactured according to IEC 80601-2-30, Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. The operational principle is based on oscillometric and silicon integrates pressure sensor technology it can calculate the systolic and diastolic blood pressure, the measurement results can also be classified by the function of blood pressure classification indicator. The Withings BP-801 is a blood pressure monitor achieves its function by integrate the device with an iPhone 4S. As it does not include a LCD or other display components, it is necessary for the new device to connect to an iPhone 4S containing a support software to constitute a complete blood pressure measurement system. And the new device connects iPhone 4S through Bluetooth or USB cable.

The Withings Blood Pressure Monitor, Upper Arm Type: HP-800 is noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to be 9'~' 7' (22cm~42cm) for Upper Arm type.

Withings Blood Pressure Monitor, Upper Arm Type:BP-800 uses the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.