# K113446: Vignet Telehealth Manager

- Pathway: 510(k) (Traditional)
- Applicant: Vignet, Inc.
- Decided: Jul 16, 2012 after 238 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). 25 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092635: Alcatel-Lucent Teleheath Manager, Alcatel-Lucent Canada, Inc. (2009) Summary page 1.
- K011779: Avidcare Series 100 Telemanagement System, Avid Care Corp. (2001) Summary page 2.
- K040966: Modification to Carematix Wellness System, Carematix, Inc. (2004) Summary page 2.

## Most influential descendants
- K122458: Verizon Wireless Remote Health Management System (2013), 2 descendants of its own
- K123671: Wellaho Personalized Outpatient Management System (2013), 2 descendants of its own
- K130971: Optum Telehealth Application (2013), 1 descendant of its own
- K171406: Optum TeleHealth Application (2017), 0 descendants of its own
- K132173: Family Healthware (2014), 0 descendants of its own

## Indications for use
The Vignet TeleHealth Manager is an accessory software application that is intended to be used by patients in non-clinical settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Vignet Telehealth Manager is intended to be used in combination with a variety of external vital sign devices. The Vignet TeleHealth Manager does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring.

Source page: https://510kreport.com/device/K113446
Methodology: https://510kreport.com/methodology