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510(k) Data Aggregation
K Number
K080091Device Name
MODIFICATION TO:HEALTH BUDDY APPLIANCE
Manufacturer
HEALTH HERO NETWORK, INC.
Date Cleared
2008-02-05
(22 days)
Product Code
DRG
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
HEALTH HERO NETWORK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Health Buddy® Appliance is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.
Device Description
The Health Buddy Appliance is a communications product that connects to a telephone line or Ethernet connection. It is used by patients in conjunction with the Health Hero Online service to answer questions and furnish information to their healthcare professional(s) between office visits. The Health Buddy Appliance contains software that can be activated to function with specific medical devices (including blood glucose meters, non-invasive blood pressure cuffs, patient weight scales, peak flow meters and pulse oximeters). The Health Buddy Appliance retrieves data from a specific medical device and stores it for transmission to a healthcare provider.
The physiologic patient parameters available for retrospective display and evaluation include pulse rate, blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements, and blood oxygen saturation (%SpO2). The Health Buddy receives connections from these medical devices, and through the data port, wireless hub, or infrared device, downloads readings from the identified attached device and transmits the responses over the telephone or Ethernet connection at predetermined times to the patient's health care professional.
The Health Buddy Appliance is a simple, user-friendly device that connects to the patient's standard home telephone line. The device connects to a Data Center via a toll-free number or an Ethernet connection to send patient responses since the previous data transfer and to retrieve the new dialogue.
The screen displays information sent by the patient's healthcare provider and asks questions about vital signs, symptoms and behaviors, and allows the patient to respond via four large buttons. The Health Buddy will respond to the patient's answers with education, reinforcement and messages that prompt patient action. The patient responses are sent to the patient's health care provider.
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K Number
K070543Device Name
MODIFICATION TO HEALTH BUDDY APPLIANCE
Manufacturer
HEALTH HERO NETWORK, INC.
Date Cleared
2007-03-28
(30 days)
Product Code
DRG
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
HEALTH HERO NETWORK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Health Buddy® Appliance is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.
Device Description
The Health Buddy appliance is a communications product that connects to a telephone line. It is used by patients in conjunction with the Health Hero Online service to answer questions and furnish information to their healthcare professional(s) between office visits. The Health Buddy appliance contains software that can be activated to function with specific medical devices (including blood glucose meters, non-invasive blood pressure cuffs, patient weight scales, peak flow meters and pulse oximeters). The Health Buddy appliance retrieves data from a specific medical device and stores it for transmission to a healthcare provider. The physiologic patient parameters available for retrospective display and evaluation include blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements, and blood oxygen saturation (%SpO₂) and pulse rate using a digital pulse oximeter. The Health Buddy receives connections from these medical devices, and through the data port, wireless hub, or infrared device, downloads readings from the identified attached device and transmits the responses over the phone lines at predetermined times to the patient's health care professional.
The Health Buddy appliance is a simple, user-friendly device that connects to the patient's standard home telephone line. The device connects to a Data Center via a toll-free number to send patient responses since the previous data transfer and to retrieve the new dialogue.
The screen displays information and asks questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons. The Health Buddy will respond to the patient's answers with education, reinforcement and messages that prompt patient action. The patient responses are sent to the patient's health care provider.
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K Number
K063612Device Name
MODIFICATION TO HEALTH BUDDY APPLIANCE
Manufacturer
HEALTH HERO NETWORK, INC.
Date Cleared
2006-12-29
(25 days)
Product Code
DRG
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
HEALTH HERO NETWORK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Health Buddy® Appliance is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.
Device Description
The Health Buddy appliance is a communications product that connects to a telephone line. It is used by patients in conjunction with the Health Hero Online service to answer questions and furnish information to their healthcare professional(s) between office visits. The Health Buddy appliance contains software that can be activated to function with specific medical devices (including blood glucose meters, non-invasive blood pressure cuffs, patient weight scales, peak flow meters and pulse oximeters). The Health Buddy appliance retrieves data from a specific medical device and stores it for transmission to a healthcare provider. The physiologic patient parameters available for retrospective display and evaluation include blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements, and blood oxygen saturation (%SpO₂) and pulse rate using a digital pulse oximeter. The Health Buddy receives connections from these medical devices, and through the data port, wireless hub, or infrared device, downloads readings from the identified attached device and transmits the responses over the phone lines at predetermined times to the patient's health care professional.
The Health Buddy appliance is a simple, user-friendly device that connects to the patient's standard home telephone line. The device connects to a Data Center via a toll-free number to send patient responses since the previous data transfer and to retrieve the new dialoque.
The screen displays information and asks questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons. The Health Buddy will respond to the patient's answers with education, reinforcement and messages that prompt patient action. The patient responses are sent to the patient's health care provider.
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K Number
K060843Device Name
MODIFICATION TO HEALTH BUDDY APPLIANCE
Manufacturer
HEALTH HERO NETWORK, INC.
Date Cleared
2006-04-20
(23 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
HEALTH HERO NETWORK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Health Buddy® Appliance is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.
Device Description
The Health Buddy appliance is a communications product that connects to a telephone line. It is used by patients in conjunction with the Health Hero Online service to answer questions and furnish information to their healthcare professional(s) between office visits. The Health Buddy appliance contains software that can be activated to function with specific medical devices (including blood glucose meters, non-invasive blood pressure cuffs, patient weight scales, peak flow meters and pulse oximeters). The Health Buddy appliance retrieves data from a specific medical device and stores it for transmission to a healthcare provider. The physiologic patient parameters available for retrospective display and evaluation include blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements, and blood oxygen saturation (%SpO₂) and pulse rate using a digital pulse oximeter. The Health Buddy receives connections from these medical devices, and through the data port, downloads readings from the identified attached device and, at predetermined times, transmits the responses over the phone lines to the patient's health care professional.
The Health Buddy appliance is a simple, user-friendly device that connects to the patient's standard home telephone line. The device connects to a Data Center via a toll-free number to send patient responses since the previous data transfer and to retrieve the new dialoque.
The screen displays information and asks questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons. The Health Buddy will respond to the patient's answers with education, reinforcement and messages that prompt patient action. The patient responses are sent to the patient's health care provider.
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K Number
K050567Device Name
HEALTH BUDDY APPLIANCE
Manufacturer
HEALTH HERO NETWORK, INC.
Date Cleared
2005-04-05
(32 days)
Product Code
DRG
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
HEALTH HERO NETWORK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Health Buddy® Appliance is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.
Device Description
The Health Buddy appliance is a communications product that connects to a telephone line. It is used by patients in conjunction with the Health Hero Online service to answer questions and furnish information to their healthcare professional(s) between office visits. The Health Buddy appliance contains software that can be activated to function with specific medical devices (including blood glucose meters, non-invasive blood pressure cuffs, patient weight scales and peak flow meters). The Health Buddy appliance retrieves data from a specific medical device and stores it for transmission to a healthcare provider. The physiologic patient parameters available for retrospective display and evaluation include blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements. In this submission, software changes are made to support hardware replacement to components no longer available in the Health Buddy. In addition, the operating system has changed. The Health Buddy device has data ports that allow it to download readings from identified attached devices, activated only upon appropriate patient enrollment.
The Health Buddy appliance is a simple, user-friendly device that connects to the patient's standard home telephone line. The device connects to a Data Center via a toll-free number to send patient responses from the previous day and to retrieve the current day's dialoque.
The screen displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons. The Health Buddy will respond to the patient's answers with education, reinforcement and messages that prompt patient action. The patient information is sent to the patient's health care provider.
The Health Buddy® is an accessory device, intended to be a communication tool to enable healthcare providers to receive historical patient information. The product is used in conjunction with Health Hero Network's Online Service, a communication tool to enable health care providers to educate, motivate, and receive patient information. Health Buddy Appliance is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
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K Number
K042273Device Name
MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY
Manufacturer
HEALTH HERO NETWORK, INC.
Date Cleared
2004-08-31
(8 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
HEALTH HERO NETWORK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Health Buddy® with Device Connectivity is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.
Device Description
The Health Buddy appliance is a communications product that connects to a telephone line. It is used by patients in conjunction with the Health Hero Online service to answer questions and furnish information to their healthcare professional(s) between office visits. The Health Buddy appliance contains software that can be activated to function with specific medical devices (including blood glucose meters, non-invasive blood pressure cuff, patient weight scale and peak flow meter). The Health Buddy with Device Connectivity retrieves data from a specific medical device and stores it for later transmission to a healthcare provider. The physiologic patient parameters available for retrospective display and evaluation include blood pressure, blood glucose level, and weight. In this submission, minor software changes are made in the Health Buddy ROM to allow it to connect to a Peak Flow Meter and monitor Peak Expiratory Flow (PEF) and FEV1 measurements. The Health Buddy has the ability to receive connections from optional, compatible devices, including those identified above, and others, such as digital thermometers, pulse oximeters and prothrombin/INR meters. The Health Buddy device has a data port that allows it to download readings from an identified attached device, activated only upon appropriate patient enrollment.
The Health Buddy with Device Connectivity is a simple, user-friendly device that connects to the patient's standard home telephone line. The device connects to the Data Center via a toll-free number to send patient responses from the previous day and to retrieve the current day's dialogue.
The screen displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons. The Health Buddy will respond to the patient's answers with education, reinforcement and messages that prompt patient action. The patient information is sent to the patient's health care provider.
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K Number
K040086Device Name
HEALTH BUDDY WITH BUDDYLINK
Manufacturer
HEALTH HERO NETWORK, INC.
Date Cleared
2004-03-10
(54 days)
Product Code
DXN, CGA
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
HEALTH HERO NETWORK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Health Buddy® with Buddylink is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.
Device Description
The Health Buddy appliance is a communications product that connects to a telephone line. It is used by patients in conjunction with the Health Hero Online service to answer questions and furnish information to their healthcare professional(s) between office visits. The Health Buddy appliance contains software that can be activated to function with specific medical devices (such as blood glucose meter, non-invasive blood pressure cuff and patient weight scale). The Health Buddy with Buddylink retrieves data from a medical device (blood glucose meter, non-invasive blood pressure cuff, or patient weight scale) and stores it for later transmission to a healthcare provider. The device has a data port that allows it to download readings from the attached device, only activated upon appropriate patient enrollment.
The Health Buddy with Buddylink is a simple; user-friendly device that connects to the patient's standard home telephone line. The device connects to the Data Center via a toll-free number to send responses from the previous day and to retrieve the current day's dialogue.
The screen displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons. The Health Buddy will respond to the patient's answers with education, reinforcement and messages that prompt patient action. The patient information is sent to the patient's health care provider.
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K Number
K993128Device Name
HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]
Manufacturer
HEALTH HERO NETWORK, INC.
Date Cleared
1999-11-23
(64 days)
Product Code
CGA
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
HEALTH HERO NETWORK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Health Buddy with Device Connect [Glucose Meter] is indicated for use in non-clinical settings to collect and transmit historical blood glucose meter data to healthcare professionals to help support effective management of diabetes patients.
Health Buddy with Device Connect is intended to be a communication tool to enable healthcare providers to receive patient blood glucose information. The product is intended to be used in conjunction with Health Hero Network Online Service, a communication tool to enable healthcare providers to educate, motivate, and receive patient information. Health Buddy with Device Connect and the Health Hero Network Online Service are not intended to provide automated treatment decisions, nor to be used as a substitute for a healthcare professional's judgment. All patient medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
Device Description
Health Buddy with Device Connect [Glucose Meter] is indicated for use in non-clinical settings to collect and transmit historical blood glucose meter data to healthcare professionals to help support effective management of diabetes patients.
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