# K103276: Intel Health Guide

- Pathway: 510(k) (Abbreviated)
- Applicant: Intel Corporation Digital Health Group
- Decided: Feb 8, 2011 after 95 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: 14 generations back to K864318 (1987). 53 ancestors in all.
10 later devices descend from it; 6 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080798: Intel Health Guide, Model: PHS6000, Intel Corp. (2008) Summary page 1.
- K083115: Modification to Intel Health Guide, Model PHS6000, Intel Corp. (2008) Summary page 1.
- K101178: Modification to Intel Health Guide PHS6000, Intel Corp. (2010) Summary page 1.

## Most influential descendants
- K122285: Tablet Commander (2012), 5 descendants of its own
- K133252: Healthinterlink Beacon (2014), 3 descendants of its own
- K181248: Comarch e-Care Platform (2018), 2 descendants of its own
- K211822: LifePath Remote Patient Monitoring Platform (2022), 1 descendant of its own
- K130290: Modification to Intel-GE Care Iinovations Guide (2013), 1 descendant of its own

## Indications for use
The Intel® Health Guide Express 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 video conferences with caregivers and answer the caregivers' questions by participating in surveys. The Intel® Health Care Management Suite allows the caregiver to review patient data and initiate video conferencing with patients, or select and send educational and motivational content to patients. The Intel® Health Guide Express 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. The Intel® Health Guide Express 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.

Source page: https://510kreport.com/device/K103276
Methodology: https://510kreport.com/methodology
