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NEOLUX X 311-40
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution
- B280864NL0040X0 ()
864NL0040X
- Ultraviolet phototherapy unit, professional
No Description
H & O Equipments SA
CryoProbe|x
In Commercial Distribution
- B386SHOCXPRXX8010 ()
S-HO-CXPR-XX-801
- General cryosurgical system, cryogen gas, mechanical
No Description
H & O Equipments SA
CryoProbe|x+
In Commercial Distribution
- B386SHOCXPRP000 ()
S-HO-CXPRP-00
- General cryosurgical system, cryogen gas, mechanical
CapSure Cloud is a secure cloud-based web application for medical image archiving and management.
Globalmed Holdings, LLC
2.1.x
Not in Commercial Distribution
- B377GMR1602008X0 ()
- Multidisciplinary medical image management 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
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
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