Health Optimizer
GUDID B553HLTHOPTIMIZERRX100
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. The following Health Optimizer insulin management feature is for prescription use only: For bolus insulin users with type 1 or type 2 diabetes, Health Optimizer 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 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 Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software| Primary Device ID | B553HLTHOPTIMIZERRX100 |
| NIH Device Record Key | 788ea2a5-db2f-45fa-aa40-0f7aecc03df6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Health Optimizer |
| Version Model Number | v1.0 |
| 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 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com | |
| Phone | 1-888-450-3664 |
| connect@welldoc.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B553HLTHOPTIMIZERRX100 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190013
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 | 2022-01-18 |
| Device Publish Date | 2022-01-10 |
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 |
Trademark Results [Health Optimizer]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEALTH OPTIMIZER 97976993 not registered Live/Pending |
CVS Pharmacy, Inc. 2021-12-02 |
 HEALTH OPTIMIZER 97152314 not registered Live/Pending |
CVS Pharmacy, Inc. 2021-12-02 |
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