Welldoc Diabetes 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. Welldoc Diabetes Rx is intended to…
Welldoc Diabetes 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. Welldoc Diabetes Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes 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. Welldoc Diabetes Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value. Welldoc Diabetes Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Welldoc | Listed by | Welldoc, United States |
| FDA product code | NDC |
| Device type | Calculator, Drug Dose |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1890 |
| Establishment | Manufacturer |
| 510(k) | K203434 |
| Record published | 2023-12-15 |
| Record revised | 2023-11-03 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2025-07-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.