VigorMist Compressor Nebulizer
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K031413 FDA 510(k)
- FDA Product Code
- BTI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.6250 FDA 510(k)
- Regulation Number
- 868.6250 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The VigorMist Compressor Nebulizer is a portable air compressor device designed for delivering aerosolized medication. It falls under the classification of a compressor nebulizer, converting liquid medication into fine mist for inhalation therapy, commonly used in anesthesiology and respiratory care settings.
This device is supplied as a reusable medical instrument, intended for use in clinical environments where precise aerosol delivery is required. It has received FDA 510(k) clearance and MDR authorization, adhering to regulatory standards for Class II devices (regulation number 868.6250). The device is not MRI-safe and must be stored in accordance with manufacturer guidelines to maintain functionality and sterility.
Frequently asked questions
Is the VigorMist Compressor Nebulizer designed for single-use or reusable applications in clinical settings?
The VigorMist Compressor Nebulizer is explicitly described as a reusable medical instrument, intended for use in clinical environments like anesthesiology and respiratory care. Since it is reusable, it must be properly cleaned, maintained, and stored according to the manufacturer’s guidelines to ensure functionality and prevent contamination between uses.
What types of clinical environments is this device primarily intended for, and why?
The VigorMist Compressor Nebulizer is primarily designed for anesthesiology and respiratory care settings, as indicated by its classification as a compressor nebulizer. It converts liquid medication into a fine mist for inhalation therapy, which is critical in procedures requiring precise aerosol delivery, such as anesthesia induction or respiratory support.
How should the VigorMist Compressor Nebulizer be stored to maintain its functionality and safety?
The device must be stored in accordance with the manufacturer’s guidelines to preserve functionality and sterility. While the data does not specify exact storage conditions (e.g., temperature or humidity), the mention of sterility maintenance implies it should be kept in a clean, dry environment, away from sources of contamination or damage, particularly if reused. Always refer to Vega Technologies’ instructions for precise storage protocols.
Can this device be used in MRI environments, or are there any safety concerns related to magnetic fields?
The VigorMist Compressor Nebulizer is not MRI-safe, meaning it should not be used in or near MRI machines. The presence of metallic or electronic components in the device could pose risks in magnetic resonance imaging environments, such as interference or potential damage to the device or patient. Always verify compatibility with MRI protocols before use.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K031413 | Class II | Active |
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Manufacturer
- Manufacturer
- Vega Technologies Inc.
- FDA Applicant
- Vega Technologies, Inc.
Sources (2)
- FDA 510(k) K031413 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026