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LifeLens Wireless ECG Monitor is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, pre-syncope, syncope, fatigue, chest pain and/or anxiety. The LifeLens Wireless ECG Monitor is intended for use by patients 18 years or older. The LifeLens Wireless ECG Monitor is not intended to be worn during defibrillation.

The LifeLens Wireless ECG Monitor is an ambulatory electrocardiograph (ECG) monitor system intended to continuously capture a single channel electrocardiogram from a subject. The Monitor consists of three components, a) disposable skin adhesive component (SAC) (also referred to as the Patch), b) reusable Hub, and c) reusable Gateway (or Gateway Recharger Case). The SAC is a single-use disposable, passive, hypoallergenic, thin, and breathable skin interface to which the Hub connects hermetically. It is placed vertically along the sternum of the subject during use. The Hub is a small, reusable, battery powered component including an electrical interface for coupling to the SAC, and hardware to record, store, and transmit the electrocardiogram from the subject during use. Additionally, the Hub includes microphones and tap detection circuitry to facilitate annotation (i.e., audio recordings) of symptoms by the user. The Gateway Recharging Case is a battery-powered device for storing and charging two Hubs, interfacing with the Hub(s) during use, storing complete patient data, and allowing users to the data after use. The Gateway receives information wirelessly over the BLE communication channel from the Hub. The Gateway manages device use and coordinates any notifications to the user about hub power status, gateway power status, etc. The system can interface wirelessly with a computer via Bluetooth LE to provide real-time data to assist in patient set-up by the Health Care Professional (HCP). The real-time data provides a means to confirm system function and signal quality. The system can also interface through the USB interface on the Gateway with a computer to offload ECG data for further archiving or analysis purposes. Only the ECG recording portion is part of this 510(k) application.