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MDLIVE Health Coaching (the software) is Software as a Medical Device (SaMD) intended to be used by individuals – aged 18 years and older – who have hypertension (high blood pressure), who have prediabetes, who enroll in the weight management program, or who enroll in the mental well-being program. The software is intended to help people with hypertension or prediabetes, or enrolled in weight management or mental well-being programs manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to provider-assisted treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates electronic reports intended for a healthcare provider. The software provides secure transfer, storage, and secondary display of data from devices such as blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. The software provides educational content to encourage behaviors that may help living well with hypertension, prediabetes, managing weight, or managing mental well-being, based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
v1.X
In Commercial Distribution
- B553202162OTC0 ()
- Medication reminder application software
TRUE MANAGER AIR APP - Android
TRIVIDIA HEALTH, INC.
TRUE MANAGER AIR APP - Android
In Commercial Distribution
- 00021292013622 ()
- Self-care monitoring/reporting software
TRUE MANAGER AIR APP - Apple iOS
TRIVIDIA HEALTH, INC.
TRUE MANAGER AIR APP - Apple iOS
In Commercial Distribution
- 00021292013196 ()
- Self-care monitoring/reporting software
ARK Care VITA is a patient mobile application of the ARK Care Advance Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes.
ARKRAY USA, INC.
Ver 1.3.
Not in Commercial Distribution
- 00015482000042 ()
- Self-care monitoring/reporting software
ReliOn Life is a patient mobile application of the ARK Care Advance Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes.
ARKRAY USA, INC.
Ver 1.3.
Not in Commercial Distribution
- 00015482000035 ()
- Self-care monitoring/reporting software
ARK Care Advance is a Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes.
ARKRAY USA, INC.
Ver 2.0.
Not in Commercial Distribution
- 00015482000028 ()
- Self-care monitoring/reporting software
ARK Care is a Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes.
ARKRAY USA, INC.
Version 2.5.3.
In Commercial Distribution
- 00015482000011 ()
- Self-care monitoring/reporting software
No Description
icometrix NV
2.2
In Commercial Distribution
- B621ICOMPANION2X2Y0 ()
- Self-care monitoring/reporting software
No Description
icometrix NV
2.1
In Commercial Distribution
- B621ICOMPANION2X1Y0 ()
- Self-care monitoring/reporting software
No Description
icometrix NV
1
In Commercial Distribution
- B621ICOMPANION103 ()
- Self-care monitoring/reporting software