# K091220: Healthanywhere System

- Pathway: 510(k) (Traditional)
- Applicant: Healthanywhere, an Igeacare System Company
- Decided: Sep 21, 2009 after 147 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: 8 generations back to K864318 (1987). 20 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050929: The Hermes System, Palaistra Systems, Inc. (2005) Summary page 3.

## Most influential descendants
- K130971: Optum Telehealth Application (2013), 1 descendant of its own
- K171406: Optum TeleHealth Application (2017), 0 descendants of its own

## Indications for use
The intended use of the HA System is for the collection, transmission, and persistence of medical measurement data and patient care data for the sole purpose of encouraging and tracking a patient's progress against the goals set between the Healthcare Professional and the patient. The goals would be established independent of the HA System in the pursuit of providing care for a chronic or post acute condition and/or to promote patient wellness. The HA System would enable Healthcare Professionals to make use of the persisted information as a guide ii delivering ongoing feedback to their patients, to set periodic reminders for patients to act on scheduled activities such as taking a vital measurement, and to receive notifications for events they configure such as am out of range vital measurement. The HA System can record physiological information such as: Blood pressure measurements Pulse rate measurements Body weight measurements Blood glucose levels Body temperature measurements Blood oxygen saturation (%SpO2) levels The HA System can be used by Healthcare Professionals to create health related questionnaires, exercise plans and nutrition plans; to forward these items to the patients; and to receive the patient responses for the related questionnaires, exercise activities, and nutrition activities. The HA System is not intended for diagnosis or as a substitute for medical care; it is also not intended to provide real-time data. The data is not used for time-critical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

Source page: https://510kreport.com/device/K091220
Methodology: https://510kreport.com/methodology