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510(k) Data Aggregation
K Number
K091220Device Name
HEALTHANYWHERE SYSTEM
Manufacturer
Date Cleared
2009-09-21
(147 days)
Product Code
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
HEALTHANYWHERE, AN IGEACARE SYSTEM COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the HA System is for the collection, transmission, and persistence of medical measurement data and patient care data for the sole purpose of encouraging and tracking a patient's progress against the goals set between the Healthcare Professional and the patient. The goals would be established independent of the HA System in the pursuit of providing care for a chronic or post acute condition and/or to promote patient wellness.
The HA System would enable Healthcare Professionals to make use of the persisted information as a guide in delivering ongoing feedback to their patients, to set periodic reminders for patients to act on scheduled activities such as taking a vital measurement, and to receive notifications for events they configure such as ar out of range vital measurement.
The HA System can record physiological information such as:
- Blood pressure measurements
- Pulse rate measurements
- Body weight measurements
- Blood glucose levels
- Body temperature measurements
- Blood oxygen saturation (%SpO2) levels
The HA System can be used by Healthcare Professionals to create health related questionnaires, exercise plans and nutrition plans; to forward these items to the patients; and to receive the patient responses for the related questionnaires, exercise activities, and nutrition activities.
The HA System is not intended for diagnosis or as a substitute for medical care; it is also not intended to provide real-time data. The data is not used for time-critical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.
Device Description
The Healthanywhere (HA) System is a user-friendly software system which provides the ability to remotely monitor basic wellness parameters. The HA System is comprised of an HA Client Application, anHA Server and the Healthcare Professional Portal (HCPP).
The HA Client Application provides capabilities to perform data collection, data transmission, message display, reminders/notifications, and reporting. It is used to collect data including vital measurements from noninvasive, commercially available, off-the-shelf, wireless medical peripherals, and patient care updates. The user data is transmitted though the HA Client Application to the HA Server using off-the-shelf. FCCapproved wireless/cellular/wired connectivity (including but not limited to GPRS, CDMA, WiFi, or Wired Ethernet) which is provided through the FCC-approved host hardware platform or through an external FCC approved wireless adapter.
The HA Server hosts the Healthcare Professional Portal (HCPP), a web application which is used to administer the HA System and users. The HCPP application provides user registration, care management, us configuration set-up, and data management. Based on specific parameters set by Healthcare Professionals, reminders and messages are scheduled and sent from the HA Server to the HA Client Applications.
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