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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
- B553202194OTC0 ()
- Medication reminder application software
Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
WELLDOC, INC.
2.X
In Commercial Distribution
- B553202193OTC0 ()
- Home pharmaceutical management support software
Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
WELLDOC, INC.
2.X
In Commercial Distribution
- B553202192OTC0 ()
- Home pharmaceutical management support software
Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
WELLDOC, INC.
2.X
In Commercial Distribution
- B553202191OTC0 ()
- Home pharmaceutical management support software
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers.
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
2.X
In Commercial Distribution
- B553202175RX0 ()
- Home pharmaceutical management support software
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
2.X
In Commercial Distribution
- B553202174RX0 ()
- Home pharmaceutical management support software
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
2.X
In Commercial Distribution
- B553202173OTC0 ()
- Home pharmaceutical management support software
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
2.X
In Commercial Distribution
- B553202172RX0 ()
- Home pharmaceutical management support software
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
2.X
In Commercial Distribution
- B553202171OTC0 ()
- Home pharmaceutical management support 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
- B553202162OTC0 ()
- Medication reminder application software