Insulia Diabetes Management Companion
FDA 510(k)Class II (US FDA 510(k))
by Voluntis Sa.
Identifiers
- 510(k) Number
- K172177 FDA 510(k)
- FDA Product Code
- NDC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1890 FDA 510(k)
- Regulation Number
- 868.1890 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Insulia Diabetes Management Companion is a Calculator, Drug Dose device (FDA regulation 868.1890) designed to assist healthcare professionals and type 2 diabetes patients in managing insulin therapy. It facilitates the secure capture, storage, and transmission of diabetes-related healthcare data, enabling structured data management and visualization through reports and graphs.
This device is intended for use in clinical settings by healthcare professionals and their patients, though it is not a medical instrument for direct patient treatment. Supplied as a software-based solution, it requires no sterility or single-use considerations. The device operates under FDA 510(k) clearance (K172177) and is classified as a Class II medical device, adhering to regulatory standards for drug dose calculators in diabetes management.
Frequently asked questions
What is the primary purpose of the Insulia Diabetes Management Companion, and who is it intended for?
The Insulia Diabetes Management Companion is a software-based calculator designed to assist healthcare professionals and type 2 diabetes patients in managing insulin therapy. It helps capture, store, and transmit diabetes-related healthcare data, enabling structured reporting and visualization through graphs. While it supports clinical workflows, it is not a direct treatment device for patients.
Is the Insulia Diabetes Management Companion a single-use or reusable device, and what sterility considerations apply?
The Insulia Diabetes Management Companion is a software-based solution supplied as a digital tool, so it does not require sterility or single-use considerations. Since it operates on a computer or mobile device, it is designed for repeated use within a clinical or patient setting.
How is the regulatory status of the Insulia Diabetes Management Companion defined, and what classification does it hold?
The Insulia Diabetes Management Companion holds FDA 510(k) clearance under the classification of a Class II medical device. It was granted clearance under the traditional review process and is categorized as a *Calculator, Drug Dose* device under FDA regulation 868.1890, ensuring compliance with drug dose calculator standards in diabetes management.
Does the Insulia Diabetes Management Companion come in physical hardware variants, or is it purely software-based?
The Insulia Diabetes Management Companion is entirely software-based and does not include physical hardware components. It operates as a digital tool, requiring no specialized equipment beyond standard computing devices (e.g., computers or smartphones) for use.
What types of data does the Insulia Diabetes Management Companion help manage, and how is it useful in clinical settings?
The device facilitates the secure capture, storage, and transmission of diabetes-related healthcare data, such as insulin dosing metrics, glucose levels, and treatment plans. This structured data management enables healthcare professionals to generate reports and graphs, improving patient monitoring and treatment adherence in clinical or home settings.
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: Insulia Diabetes Management Companion by Voluntis S.A. | FDA 510 (k ..., K202596 FDA 510(k) - Insulia Diabetes Management Companion, Insulia® - 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 | K172177 | Class II | Active |
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Manufacturer
- Manufacturer
- Voluntis Sa.
Sources (1)
- FDA 510(k) K172177 24 fields · synced Sep 19, 2026