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The Happy Health Home Sleep Test is a Software as a Medical Device that uses data from wearable devices to record, analyze, display, export, and store biophysical parameters to aid in evaluating sleep‐related breathing disorders of adult patients suspected of sleep apnea. The device is intended for use on individuals who are 22 years of age or older in clinical and home settings under the direction of a trained healthcare provider.

The Happy Health Home Sleep Test is a Software as a Medical Device that uses data from wearable devices to record, analyze, display, export, and store biophysical parameters to aid in evaluating sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for use on individuals who are 22 years of age or older in clinical and home settings under the direction of a trained healthcare provider. The device is intended to process input data streams received from an external hardware device (i.e., a smart ring, K240236) and uses these signals to determine various sleep parameters that may be used and interpreted by a clinician in diagnosing sleep disorders such as sleep apnea. The input physiologic signals from the external device are: - Acceleration / Movement - Photoplethysmography (PPG) The external hardware device (K240236) includes a PPG sensor and accelerometer embedded within a housing to capture the above physiological signals. The K240236 device is worn on the finger and is indicated for continuous data collection of the above signals. Data from the external hardware device is transmitted over a secure API to the subject device for analysis. The device then uses a set of algorithms to compute the following outputs: - Happy Health Apnea Hypopnea Index (hAHI) - Total Sleep Time The outputs are available for a clinician to review as a report, accessible through a web-based viewer application.

The Happy Ring Health Monitoring System is a wearable device system to remotely monitor physiologic parameters of patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. The device is intended for use on individuals who are 22 years of age or older. The device supports continuous data collection for monitoring of the following physiological parameters: - Acceleration / Movement - Electrodermal Activity (EDA) - Blood Oxygen Saturation - Pulse Rate - Peripheral Skin Temperature The Happy Ring Health Monitoring System is intended for peripheral skin temperature monitoring, where monitoring temperature at the finger is clinically indicated. The Happy Ring Health Monitoring System is not intended for SpO2, pulse rate, respiration rate monitoring in conditions of motion or low perfusion.

The Happy Ring Health Monitoring System is a wearable device and software platform comprising: - A wearable medical device smart ring, - A mobile app-based bluetooth-to-internet gateway, - A cloud-based API, - A set of data processing algorithms, and - A Physician data viewer.The Ring is worn on the user's finger and continuously collects raw data via specific sensors. These raw data are transmitted via Bluetooth Low Energy to a paired mobile device. The data received are transmitted by the mobile app gateway, via the cloud-based AP, to the data processing algorithms where various physiological parameters are computed. The raw and processed data are stored, further analyzed, and accessible by healthcare providers or researchers via the Physician data viewer. The Happy Ring Health Monitoring System is intended for retrospective remote monitoring of physiological parameters in ambulatory adults in home-healthcare environments. It is designed to continuously collect data to support intermittent monitoring of the following physiological parameters by trained healthcare professions or researchers: Acceleration / movement, electrodermal activity (EDA), blood oxygen saturation, pulse rate, and peripheral skin temperature.