Indications For Use and Safety Information

The Embrace2 is a prescription only device that is indicated for use as an adjunct to seizure monitoring of adults and children ages 6 and up in home or healthcare facilities during periods of rest. The device is worn on the wrist and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with generalized tonic-clonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, Embrace sends a command to a paired wireless device that is programmed to initiate an alert to a designated caregiver. The system records and stores data from Accelerometer, EDA, and Temperature sensors for subsequent review by a trained healthcare professional.

Limitations

• The device does not predict seizure onset.
• The device is not intended to be used during physical activity.
• The safety and effectiveness of the Embrace System has not been established in monitoring signals that may be associated with seizures other than generalized tonic-clonic convulsive seizures.
• The device is not intended to be used to guide medical therapy decisions.
• The device is not intended to be used as a stand-alone monitoring device.

Important safety information and risks

Empatica cannot guarantee that Embrace2 and the Alert App will detect every single seizure and deliver alerts accordingly. The system is not meant to substitute your current seizure monitoring practices, but rather to serve as a supplement in expediting first-response time. It is important to not alter current seizure management practices when using Embrace2.The main risk associated with the Embrace2 and Alert App is the device failing to detect a convulsive seizure, or failing to deliver an alert due to connection issues. If the user or caregiver changes their seizure management practices and relies too heavily on Embrace2, this may lead to less than adequate supervision. Patients should discuss the risks and benefits of Embrace2 with their physician.

The above information is a summary of important information reported in the device labeling. The information is not intended as a substitute for a complete understanding of the Embrace system, nor does it represent full disclosure of all relevant information concerning the product.