WellDoc Diabetes Manager System and Diabetes Manager Rx System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K120314 FDA 510(k)
- FDA Product Code
- MRZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The WellDoc Diabetes Manager System and Diabetes Manager Rx System are digital health devices designed for diabetes management. These systems provide remote monitoring, personalized coaching, and insulin management support for patients with type 1 or type 2 diabetes, integrating clinical data to deliver evidence-based guidance. The Diabetes Manager Rx System includes prescription-based insulin management features for bolus insulin users, enabling tailored insulin dosing recommendations.
The systems are supplied as software-based solutions, intended for use by healthcare providers and their adult patients. They are not classified as single-use or reusable medical devices but are regulated under FDA 510(k) clearance (K120314) as substantially equivalent to predicate devices. The systems operate in clinical settings, such as general hospitals, and are intended for use with compatible insulin pumps and accessories as referenced in the regulatory filings. No sterility or physical device packaging specifications are provided.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Diabetes Management | AI Healthcare | Welldoc, Welldoc | Healthcare-Ready AI, Welldoc App - Digital Therapeutics Alliance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120314 | Class II | Active |
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Manufacturer
- Manufacturer
- Welldoc, Inc.
Sources (1)
- FDA 510(k) K120314 24 fields · synced Sep 20, 2026