# K101178: Modification to Intel Health Guide PHS6000

- Pathway: 510(k) (Special)
- Applicant: Intel Corp.
- Decided: Jun 29, 2010 after 63 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: 13 generations back to K864318 (1987). 52 ancestors in all.
11 later devices descend from it; 1 cites 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.

## Most influential descendants
- K103276: Intel Health Guide (2011), 10 descendants of its own
- 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

## Indications for use
The Intel® Health Guide PHS6000 is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. It collects measurements captured on commercially available wireless or tethered medical devices designed for home use, stores and displays the collected information on the LCD screen, and transmits the information to a secure host server; Caregivers can review the transmitted information and select education and reminders for patients using a caregiver software interface to the host server. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also optionally engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys. The Intel® Health Guide PHS6000 is not 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. It 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/K101178
Methodology: https://510kreport.com/methodology