MDLIVE Health Coaching

GUDID B553202162OTC0

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.

Medication reminder application software

• Primary Device ID: B553202162OTC0
• NIH Device Record Key: 7d7c6573-58bc-4a41-8cf2-cc78f546e786
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MDLIVE Health Coaching
• Version Model Number: v1.X
• Company DUNS: 021217115
• Company Name: WELLDOC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-888-450-3664
• Email: connect@welldoc.com
• Phone: 1-888-450-3664
• Email: connect@welldoc.com
• Phone: 1-888-450-3664
• Email: connect@welldoc.com
• Phone: 1-888-450-3664
• Email: connect@welldoc.com
• Phone: 1-888-450-3664
• Email: connect@welldoc.com
• Phone: 1-888-450-3664
• Email: connect@welldoc.com
• Phone: 1-888-450-3664
• Email: connect@welldoc.com
• Phone: 1-888-450-3664
• Email: connect@welldoc.com
• Phone: 1-888-450-3664
• Email: connect@welldoc.com
• Phone: 1-888-450-3664
• Email: connect@welldoc.com
• Phone: 1-888-450-3664
• Email: connect@welldoc.com
• Phone: 1-888-450-3664
• Email: connect@welldoc.com
• Phone: 1-888-450-3664
• Email: connect@welldoc.com
• Phone: 1-888-450-3664
• Email: connect@welldoc.com
• Phone: 1-888-450-3664
• Email: connect@welldoc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B553202162OTC0 [Primary]

FDA Product Code

• NXQ: Reminder, Medication

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-21
• Device Publish Date: 2025-04-11

On-Brand Devices [MDLIVE Health Coaching]

• B553202162OTC0: MDLIVE Health Coaching (the software) is Software as a Medical Device (SaMD) intended to be used
• B553202161OTC0: MDLIVE Health Coaching (the software) is Software as a Medical Device (SaMD) intended to be used