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The ALLY™ Platform System is a multi-platform medical device that is an accessory to approved 510k devices and is intended to be used as a means of receiving, storing, and transmitting patient biometric data including vital signs measurements. The ALLY™ Platform System is to be used upon prescription and under the supervision of an authorized healthcare provider. The ALLY " Platform System will send information to a remote database to be accessed by authorized clients, such as healthcare professionals or patient family members. Electronic data consisting of patient vital sign information, educational material, reminders, questionnaires, and patient responses are exchanged over a secure network connection. Information may be communicated via standard telephone lines, high speed internet connections, serial port interfaces, or Bluetooth® radio transceivers. The ALLY™ Platform is a multi-platform application that is not intended to provide automated treatment decisions or perform data manipulation, diagnostics, or real-time alerts. The ALLY™ Platform is not intended to act as an emergency response system. All patient medical diagnosis and treatment are to be performed by an appropriate health care professional.

ALLY™ is comprised of a home unit, legally marketed diagnostic peripherals, and a server. The home unit is a communications device that collects data from the diagnostic peripherals and. The patient in the home and transmits the data to the server over the home's existing telephone line or other identified method (existing high-speed connection in patients' home). The diagnostic peripherals comprise a wide range of legally marketed medical electronic devices capable of measuring patient parameters such as blood pressure, pulse rate, weight, etc. The server application responds to calls from the home units, collects the data, and then compares the data to preset thresholds. The healthcare practitioners and privileged users access the server through a secure website. ALLYTM Care Portal: The ALLY TM Care Portal is intended to be used as an accessory to communication tools, such as the ALLYTM Home Appliance (RTX 337X). The ALLY TM Care Portal enables healthcare providers to request, receive, and review historical patient information. It is intended to be used in combination with a variety of external devices. ALLYTM Home Appliance (RTX 337X): The ALLYTM Home Appliance (RTX 337X) is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable healthcare providers to receive historical patient information. It is intended to be used in combination with a variety of external devices. The ALLY™ Home Appliance (RTX 337X) serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management center or with the healthcare/wellness provider or other out of hospital caregivers.