# K093895: Ally Platform System

- Pathway: 510(k) (Traditional)
- Applicant: Continuity Health Solutions
- Decided: May 20, 2010 after 153 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K864318 (1987). 73 ancestors in all.
No later device cites it as a predicate yet.
1 of 74 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090801: Electronic House Call, Express MD Solutions, LLC (2009) Summary page 1.
- K063612: Modification to Health Buddy Appliance, Health Hero Network, Inc. (2006) Summary page 1.

## Indications for use
The ALLYT 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 biomnetric. data including vital signs measurements. The ALLYm Platform System is to be used upon prescription and under the supervision of an authorized healthcare provider. The ALLYT 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 intermet connections, serial port interfaces, or BluetoothO radio transceivers. The ALLYT 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 ALLYm 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.

Source page: https://510kreport.com/device/K093895
Methodology: https://510kreport.com/methodology