# K130676: Ambio Remote Health Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Arrayent Health, LLC D/B/A Ambio Health
- Decided: Jul 8, 2013 after 118 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). 60 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062377: Medapps Remote Patient Monitoring, Model MA 100, Medapps, Inc. (2007) Summary page 1.
- K111932: Iglucose System, Positiveid Corporation (2011) Summary page 1.
- K080798: Intel Health Guide, Model: PHS6000, Intel Corp. (2008) Summary page 1.

## Most influential descendants
- K132148: S Health (2013), 0 descendants of its own

## Indications for use
The Ambio Remote Health Monitoring System ("System") consists of Amblo Wireless Connectors to send readings from off-the-shelf blood pressure and blood glucose meters; the Amblo Scale with built in wireless connectivity to send readings through the Ambio Gateway to the Ambio Care Portal. The Care Portal is used by patients and their caregivers ("Users") to view readings, set reminders to take meter readings and pills, set reading thresholds which will trigger alert messages and set who will get reminder and alert messages. Reading history can be printed or exported. Users can maintain an exercise log, food log and records of doctor visits and lab tests. Users can set goals and rewards for taking readings and for keeping readings in target ranges. A patient survey tool can be used to gather qualitative health information. The System also has a shared calendar and message board to coordinate among Users. General health information from accredited sources is also available. The Ambio Remote Health Monitoring System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The System does not alter the indicated use of the described blood pressure or blood glucose monitors.

Source page: https://510kreport.com/device/K130676
Methodology: https://510kreport.com/methodology