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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
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
- B553202161OTC0 ()
- Medication reminder application software
Health Optimizer for Rare Condition Members is Software as a Medical Device intended to help patients live well with their rare conditions and comorbidities. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to 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 which may help living well with rare conditions and comorbidities based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining 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.
v2.X
In Commercial Distribution
- B553202195OTC0 ()
- 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
Lilly Health Personalized Health & Medicine Platform is intended for providing medication reminders, medication dose logging, and health data logging, depending
upon the medicinal product prescribed or condition.
WELLDOC, INC.
1.X
In Commercial Distribution
- B553202202OTC0 ()
- Medication reminder application software
Lilly Health Personalized Health & Medicine Platform is intended for providing medication reminders, medication dose logging, and health data logging, depending
upon the medicinal product prescribed or condition.
WELLDOC, INC.
1.X
In Commercial Distribution
- B553202201OTC0 ()
- Medication reminder application software
QG-TV-CM
CARESTREAM HEALTH, INC.
DRX - Ascend System
In Commercial Distribution
- 60889976574645 ()
6574644
- X-ray system computer, diagnostic, general-purpose
QG-TV10-C TECHVISION RS-590 WITH Q-VISIO
CARESTREAM HEALTH, INC.
DRX - Ascend System
In Commercial Distribution
- 60889976574638 ()
6574636
- X-ray system computer, diagnostic, general-purpose
QG-TV10-IPF-MAT TECHVISION QS-550 DRX AT
CARESTREAM HEALTH, INC.
QG-TV-IP-FM
In Commercial Distribution
- 60889976573341 ()
6573349
- X-ray system computer, diagnostic, general-purpose