Intel Health Guide PHS6000
by Intel Corp.
510(k) K101178
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101178 | Date29 Jun 2010 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Modification to Intel Health Guide PHS6000
- 510(k) Number
- FDA Product Code
- DRG
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2910
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Intel Health Guide PHS6000 is a Transmitter and Receiver, Physiological Signal, Radiofrequency (per FDA classification). It functions as a communication device designed to remotely collect, store, and transmit vital sign measurements from wireless or tethered medical devices used in home settings. The device aggregates data from compatible patient monitoring tools and displays it on an LCD screen for caregiver review.
The PHS6000 is supplied as a standalone unit intended for use in home healthcare environments. It operates as a reusable, non-sterile device and does not require MRI compatibility considerations. The system integrates with commercially available physiological monitoring devices, enabling remote patient monitoring. Authorized under FDA 510(k) clearance (K101178), it adheres to regulatory standards for Class II medical devices under 21 CFR 870.2910. No specific sterility or single-use requirements are noted in the regulatory submission.
Other devices from Intel Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Intel Health Guide PHS6000 used for?
The Intel Health Guide PHS6000 is a transmitter and receiver designed for remote physiological signal monitoring. It aggregates vital sign data from wireless or tethered medical devices used in home settings, allowing caregivers to review measurements on an integrated LCD screen. This facilitates continuous remote patient monitoring, particularly useful for chronic conditions like cardiovascular health.
How is the Intel Health Guide PHS6000 supplied and what are its key features?
The PHS6000 is supplied as a standalone, reusable unit intended exclusively for home healthcare environments. It does not require sterilization or single-use handling, as it is classified as non-sterile. The device integrates with commercially available physiological monitoring tools, enabling seamless data transmission and aggregation for caregiver assessment.
Is the Intel Health Guide PHS6000 compatible with MRI environments?
No, the Intel Health Guide PHS6000 does not require MRI compatibility considerations. It is designed for use in non-MRI settings, such as home healthcare environments, where remote monitoring is the primary application.
What regulatory pathway does the Intel Health Guide PHS6000 follow?
The Intel Health Guide PHS6000 is authorized under an FDA 510(k) clearance (K101178) and classified as a Class II medical device under 21 CFR 870.2910. This regulatory pathway confirms its substantial equivalence to a predicate device and adherence to safety and performance standards for physiological signal transmitters and receivers.
Which types of physiological monitoring devices can the PHS6000 integrate with?
The PHS6000 is designed to integrate with commercially available physiological monitoring devices that support wireless or tethered data transmission. While the exact compatible devices are not specified, its primary function is to aggregate and display vital sign measurements (e.g., heart rate, blood pressure) from these tools, enabling remote caregiver review. Check manufacturer documentation for specific device compatibility.