# K130971: Optum Telehealth Application

- Pathway: 510(k) (Traditional)
- Applicant: Optumhealth Care Solutions, Inc.
- Decided: Oct 23, 2013 after 198 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: 12 generations back to K864318 (1987). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113446: Vignet Telehealth Manager, Vignet, Inc. (2012) Summary page 1.
- K112858: Genesis Touch System, Honeywell Hommed, LLC (2012) Summary page 1.
- K091220: Healthanywhere System, Healthanywhere, an Igeacare System Company (2009) Summary page 1.
- (no number) GenesisTouch System: named in the summary without a submission number

## Most influential descendants
- K171406: Optum TeleHealth Application (2017), 0 descendants of its own

## Indications for use
The Optum TeleHealth Application is a software application designed to retrospectively monitor vital signs. The following vital signs are collected: noninvasive blood pressure, pulse oximetry, pulse rate, weight, temperature, and blood glucose. The Optum TeleHealth Application collects, displays, and transmits vital sign measurements captured from commercially available FDA cleared medical devices designed for home use, or via manual input by the patient. Collected measurement data from the Optum TeleHealth Application can be transmitted via a secure communication mechanism to a central health data repository. Data can be viewed and analyzed via the Optum TeleHealth Web Application. The Optum TeleHealth Application is not intended for emergency use or real-time monitoring. The client application is available in two configurations: * stand-alone application * pre-loaded on an Android tablet

Source page: https://510kreport.com/device/K130971
Methodology: https://510kreport.com/methodology