DiabetesManager System, DiabetesManager-Rx System Model Version 1.1
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100066 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 DiabetesManager System, DiabetesManager-Rx System Model Version 1.1 is a medical computer designed for diabetes management. It is classified as an accessory for infusion pumps and supports remote monitoring and data analysis for patients with type 2 diabetes, facilitating clinical decision-making and patient engagement through software-based tracking and reporting.
This system is intended for use in general hospital settings and has received FDA 510(k) clearance under the Traditional review pathway. Supplied as a reusable device, it operates in conjunction with compatible infusion pumps and requires no specific sterility beyond standard medical device hygiene protocols. The system is regulated under FDA regulation number 880.5725 and is associated with multiple registration numbers for related accessories. No MRI safety information is provided.
Frequently asked questions
What is the DiabetesManager-RX System V1.1 used for?
The DiabetesManager-RX System V1.1 is a medical computer accessory for infusion pumps, specifically designed to assist in managing type 2 diabetes in hospital settings. It enables remote monitoring and data analysis, helping clinicians make informed decisions while engaging patients through software-based tracking and reporting of diabetes-related metrics.
Is the DiabetesManager-RX System V1.1 a single-use or reusable device?
The DiabetesManager-RX System V1.1 is a reusable device. It is intended for repeated use in hospital environments, provided it adheres to standard medical device hygiene protocols. Unlike single-use devices, it does not require disposal after each procedure.
What sterility or cleaning requirements apply to the DiabetesManager-RX System V1.1?
The DiabetesManager-RX System V1.1 does not require specific sterility beyond standard medical device hygiene protocols. Since it is reusable, proper cleaning and maintenance are essential to prevent contamination and ensure reliable operation in clinical settings.
Can the DiabetesManager-RX System V1.1 be used with any infusion pump?
The DiabetesManager-RX System V1.1 is designed to operate in conjunction with *compatible* infusion pumps. While it supports remote monitoring and data analysis, compatibility with specific pump models must be verified to ensure seamless integration and accurate functionality.
What regulatory pathway was followed for FDA clearance of this device?
The DiabetesManager-RX System V1.1 received FDA 510(k) clearance under the Traditional review pathway, demonstrating its substantial equivalence to a predicate device. This clearance confirms its safety and effectiveness for use as an accessory in hospital-based 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: Diabetesmanager System, Diabetesmanager-rx System Model Version 1.1, DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM… - FDA.report, Welldoc Diabetes Manager System and Diabetes Manager Rx System (K120314 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100066 | Class II | Active |
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Manufacturer
- Manufacturer
- Welldoc, Inc.
Sources (1)
- FDA 510(k) K100066 24 fields · synced Oct 1, 2026