Healthfirst Cares is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Healthfirst Cares is intended to…
Healthfirst Cares is indicated for use by healthcare providers (HCPs) and their patients → aged 18 years and older – who have type 1 or type 2 diabetes. Healthfirst Cares is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. Healthfirst Cares analyzes, and reports glucose test results and supports medication adherence. In addition, Healthfirst Cares provides coaching messages (motivational, behavioral, and educational) based on real-time 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.
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 Healthfirst Cares | 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 | 2023-03-06 |
| Record revised | 2023-11-03 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2025-05-15 |
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.