Health Optimizer for Rare Condition Members

GUDID B553202194OTC0

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.

Medication reminder application software

• Primary Device ID: B553202194OTC0
• NIH Device Record Key: f1d692a1-414f-47b5-8729-4278aa6ebf92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health Optimizer for Rare Condition Members
• Version Model Number: v2.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	B553202194OTC0 [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 [Health Optimizer for Rare Condition Members]

• B553202195OTC0: Health Optimizer for Rare Condition Members is Software as a Medical Device intended to help pat
• B553202194OTC0: Health Optimizer for Rare Condition Members is Software as a Medical Device intended to help pat