# K130821: Intel-GE Care Innovations Connect RCM

- Pathway: 510(k) (Abbreviated)
- Applicant: Intel-Ge Care Innovations, LLC
- Decided: Aug 9, 2013 after 137 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: 16 generations back to K864318 (1987). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130290: Modification to Intel-GE Care Iinovations Guide, Intel-Ge Care Innovations, LLC (2013). Cleared while this submission was under review Summary page 1.
- K123671: Wellaho Personalized Outpatient Management System, Sanitas, Inc. (2013) Summary page 1.
- K113446: Vignet Telehealth Manager, Vignet, Inc. (2012) Summary page 1.

## Indications for use
Intel-GE Care Innovations Connect RCM is intended to collect vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also engage in videoconferences with caregivers and answer the caregivers' questions by participating in surveys. Care Innovations Connect RCM is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. Care Innovations Connect RCM is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered. Care Innovations Connect RCM will be available for over the Counter use.

Source page: https://510kreport.com/device/K130821
Methodology: https://510kreport.com/methodology