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510(k) Data Aggregation
K Number
K122458Device Name
VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM
Manufacturer
CELLO PARTNERSHIP D/B/A VERIZON WIRELESS
Date Cleared
2013-07-30
(351 days)
Product Code
DRG
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
CELLO PARTNERSHIP D/B/A VERIZON WIRELESS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CHM Device is a remote monitoring software solution intended to collect and store biometric data from physiological measurement devices intended for use in the home. The CHM Device also allows for the automated transmission of the biometric data to a remote secure server via existing mobile telecommunications and/or Internet infrastructure.
The stored biometric data is accessible by clinicians for analysis and intervention. Patients can also review the stored biometric data and receive educational content from clinicians.
The CHM Device can be used as a standalone device or in conjunction with supported patient monitoring devices, such as a glucometer, weight scale, pulse oximeter, and blood pressure monitor.
The CHM Device is not intended for use in surgical rooms, intensive care units, intermediate or stepdown units or emergency vehicles. It is not interpretive, nor is it intended for diagnosis or as a replacement for the oversight of healthcare professionals. It does not provide real-time or emergency monitoring.
Device Description
The CHM Device is a software platform for the collection and display of biometric data, primarily from externally supported patient monitoring devices, both to the clinician. The CHM Device may also be used as a standalone device. The CHM Device uses existing Internet and telecommunications architecture (cellphones and computers) for the automated transmission of medical data to a remote server from where it can be viewed remotely by clinicians and patients for the purposes of storage and basic analysis. The CHM Device also provides educational and motivational functionalities allowing the clinician to send tasks, recommendations, surveys, and educational and motivational messages to patients.
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