Health Optimizer

GUDID B553202192OTC0

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.

Home pharmaceutical management support software

• Primary Device ID: B553202192OTC0
• NIH Device Record Key: e377d305-ab30-4119-b071-796cfc3c2345
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health Optimizer
• Version Model Number: 2.X
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B553202192OTC0 [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: 2024-07-15
• Device Publish Date: 2024-07-05

On-Brand Devices [Health Optimizer]

• B553HLTHOPTIMIZERRX100: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients - aged
• B553HLTHOPTIMIZER100: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients - aged
• B553HLTHOPTIMIZER110: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients - aged
• B553HLTHOPTIMIZER120: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – ag
• B553HLTHOPTIMIZER130: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – ag
• B553HLTHOPTIMIZER140: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – ag
• B553HLTHOPTIMIZER160: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – ag
• B553HLTHOPTIMIZER170: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – ag
• B553HLTHOPTIMIZER150: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – ag
• B553HLTHOPTIMIZER180: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – ag
• B553HLTHOPTIMIZER190: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – ag
• B553202093OTC0: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – ag
• B553202092OTC0: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – ag
• B553202091OTC0: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – ag
• B553202193OTC0: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – ag
• B553202192OTC0: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – ag
• B553202191OTC0: Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – ag