Insulia Diabetes Management Companion
FDA 510(k)Class II (US FDA 510(k))
by Voluntis Sa.
Identifiers
- 510(k) Number
- K161433 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 for drug dose used in diabetes management. It is intended to provide secure capture, storage and transmission of diabetes-related healthcare information, enhance data management, display reports and graphs, and aid healthcare professionals and patients in reviewing, analyzing, and evaluating patient data to support effective diabetes management.
The device is supplied for use by healthcare professionals and their type 2 adult diabetes patients treated with long-acting insulin analog. It has FDA 510(k) clearance with product code NDC and is classified as a class II device. The device is manufactured by Voluntis S.A. in Paris, France.
Frequently asked questions
What is the Insulia Diabetes Management Companion used for?
The Insulia Diabetes Management Companion is a calculator for drug dose used in diabetes management. It helps healthcare professionals and patients with type 2 diabetes treated with long-acting insulin analog by providing secure capture, storage, and transmission of diabetes-related healthcare information.
How is the Insulia Diabetes Management Companion supplied?
The device is supplied for use by healthcare professionals and their type 2 adult diabetes patients treated with long-acting insulin analog. It is manufactured by Voluntis S.A. in Paris, France.
What is the regulatory status of the Insulia Diabetes Management Companion?
The device has FDA 510(k) clearance with product code NDC and is classified as a class II device. It received clearance on November 9, 2016, with decision code SESE indicating substantial equivalence.
What features does the Insulia Diabetes Management Companion offer?
The device enhances data management, displays reports and graphs, and aids healthcare professionals and patients in reviewing, analyzing, and evaluating patient data to support effective diabetes management.
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 ..., Insulia® - Digital Therapeutics Alliance, K202596 FDA 510(k) - Insulia Diabetes Management Companion
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161433 | Class II | Active |
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Manufacturer
- Manufacturer
- Voluntis Sa.
Sources (1)
- FDA 510(k) K161433 24 fields · synced Sep 24, 2026