# K123671: Wellaho Personalized Outpatient Management System

- Pathway: 510(k) (Traditional)
- Applicant: Sanitas, Inc.
- Decided: Jan 16, 2013 after 48 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). 26 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 29 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)

## Most influential descendants
- K132173: Family Healthware (2014), 0 descendants of its own
- K130821: Intel-GE Care Innovations Connect RCM (2013), 0 descendants of its own

## Indications for use
The WellahoTM Personalized Outpatient Management System is an accessory software application that is 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 usinig standard digital communication technologies 'and protocols. The Wellaho is also intended to be used in combination with a variety of external vital sign devices. The Wellaho Personalized Outpatient Management System 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/K123671
Methodology: https://510kreport.com/methodology