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510(k) Data Aggregation
K Number
K101178Device Name
MODIFICATION TO INTEL HEALTH GUIDE PHS6000
Manufacturer
INTEL CORP.
Date Cleared
2010-06-29
(63 days)
Product Code
DRG
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
INTEL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
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 system consists of the:
- Intel® Health Guide PHS6000 hardware: The physical component of the Intel® Health Guide PHS6000 is an electronic device contained in a plastic enclosure with a touch screen, video camera with privacy screen, microphones, speakers and a reminder light which is mounted into the top of the case. On the back of the device is a power socket, a headphone socket, a Broadband (high-speed) internet socket for connection to a broadband network. The device has medical device sockets for connection to specific physiological monitors, and may optionally have a phone socket for modem connection to a standard phone line.
- Intel® Health Guide software application: The software application captures, stores, and transmits information to a secure website via a standard telephone line or a LAN/WAN connection.
- Intel® Care Management Suite software application: The application allows caregivers to review patient vital signs on the secure website. The Intel® Care Management Suite allows for predefining upper and lower limits and, when either limit is exceeded, the system emails and/or pages the caregiver.
- Processor software application: The processor software application manages the interface between the Intel® Health Guide PHS6000 software application and the secure website.
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. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The device 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.
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K Number
K083115Device Name
MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000
Manufacturer
INTEL CORP.
Date Cleared
2008-11-26
(36 days)
Product Code
DRG, CGA, LFR
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
INTEL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
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 system consists of the:
- Intel® Health Guide PHS6000 hardware: The physical component is an electronic device with a touch screen, video camera with privacy screen, microphones, speakers and a reminder light. It has a power socket, headphone socket, Broadband internet socket, medical device sockets, and optionally a phone socket.
- Intel® Health Guide software application: Captures, stores, and transmits information to a secure website.
- Intel® Care Management Suite software application: Allows caregivers to review patient vital signs on the secure website and set limits for alerts.
- Processor software application: Manages the interface between the Intel® Health Guide PHS6000 software application and the secure website.
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. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The device 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.
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K Number
K080798Device Name
INTEL HEALTH GUIDE, MODEL: PHS6000
Manufacturer
INTEL CORP.
Date Cleared
2008-06-27
(99 days)
Product Code
DRG
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
INTEL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
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 remotely access vitar ago 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 scrver. 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 Screef. Fattents can review the pregivers. Patients can also optionally engage in cultianonia and morractorers and answer the caregivers` questions by participating in surveys.
The Intel" Health Guide PHS6000 system consists of the:
- Intel* Health Guide PHS6000 hardware: (1)
The physical component of the Intel® Health Guide PHS6000 is an electronic device contained in a plastic enclosure with a touch screen, video camera with privacy screen, microphones, speakers and a reminder light which is mounted into the top of the case. On the back of the device is a power socket, a headphone socket. a Broadband (high-speed) internet socket for connection to a broadband network. The device has medical device sockets for connection to specific physiological monitors, and may optionally have a phone socket for modem connection to a standard phone line.
- Intel " Health Guide software application: (2)
The software application captures, stores, and transmits information to a secure website via a standard telephone line or a LAN/WAN connection.
- Intel* Care Management Suite software application: (3)
The application allows caregivers to review patient vital signs on the secure website. The Intel® Care Management Suite allows for predetining upper and lower limits and, when either limit is exceeded, the system emails and/or pages the caregiver.
- Processor software application: (4)
The processor software application manages the interface between the Intel® Health Guide PHS6000 software application and the secure website.
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. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The device 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.
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