Health Optimizer Rx

GUDID B553HLTHOPTIMIZERX130

Health Optimizer® Rx 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 Rx 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 Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer Rx 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. The following Health Optimizer Rx insulin management feature is for prescription use only: For bolus insulin users with type 1 or type 2 diabetes, Health Optimizer Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. Health Optimizer Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

WELLDOC, INC.

Pharmaceutical management support software, patient-/professional-use

• Primary Device ID: B553HLTHOPTIMIZERX130
• NIH Device Record Key: e5c523cb-fe76-4637-806d-55d76d2646c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health Optimizer Rx
• Version Model Number: v1.3
• Company DUNS: 021217115
• Company Name: WELLDOC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B553HLTHOPTIMIZERX130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193654

FDA Product Code

• MRZ: Accessories, Pump, Infusion

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: 2022-08-12
• Device Publish Date: 2022-08-04

On-Brand Devices [Health Optimizer Rx]

• B553HLTHOPTIMIZERX110: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients - aged
• B553HLTHOPTIMIZERX120: Health Optimizer® Rx is indicated for use by healthcare providers (HCPs) and their patients - a
• B553HLTHOPTIMIZERX130: Health Optimizer® Rx is indicated for use by healthcare providers (HCPs) and their patients - a
• B553HLTHOPTIMIZERX140: Health Optimizer® Rx is indicated for use by healthcare providers (HCPs) and their patients - a
• B553HLTHOPTIMIZERRX160: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – ag
• B553HLTHOPTIMIZERRX170: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – ag
• B553HLTHOPTIMIZERX150: Health Optimizer® Rx is indicated for use by healthcare providers (HCPs) and their patients - a