Pulmogine Vibrating Mesh Nebulizer
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K202171 FDA 510(k)
- FDA Product Code
- CAF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5630 FDA 510(k)
- Regulation Number
- 868.5630 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pulmogine Vibrating Mesh Nebulizer is a handheld, portable aerosol delivery device that uses vibrating mesh technology to produce fine mist for inhalation therapy. It is classified as a general-purpose nebulizer designed to administer liquid medications directly to the respiratory tract, facilitating treatment of conditions requiring aerosolized drug delivery.
This device is powered internally and operates in continuous output mode, enabling consistent aerosol generation for therapeutic use. Supplied as a single-use or reusable system (as specified by the manufacturer), it adheres to FDA 510(k) clearance and MDD compliance standards. The Pulmogine is intended for use in clinical and home settings, with no specific MRI safety restrictions noted in the regulatory data.
Frequently asked questions
What types of respiratory conditions is the Pulmogine Vibrating Mesh Nebulizer designed to treat, and how does it differ from other nebulizers?
The Pulmogine is a general-purpose nebulizer intended for delivering liquid medications directly to the respiratory tract as fine mist via inhalation. While it isn’t specified for any particular condition in the data, its vibrating mesh technology ensures consistent aerosol output in continuous mode, making it suitable for therapies requiring precise drug delivery—such as asthma, COPD, or cystic fibrosis treatments. Unlike traditional jet or ultrasonic nebulizers, it avoids heat or noise generation, which may improve patient comfort and medication stability for temperature-sensitive drugs.
Is the Pulmogine available as a single-use or reusable device, and how should it be handled to maintain performance?
The Pulmogine can be supplied as either single-use or reusable, depending on the specific model or configuration chosen by the manufacturer. For reusable units, proper cleaning and maintenance per manufacturer instructions are critical to prevent contamination and ensure consistent aerosol output. Single-use versions eliminate the need for sterilization but should be discarded after one use to avoid cross-infection risks. Neither option requires special storage conditions beyond those recommended for medical devices.
What are the key differences between the FDA and MDD compliance routes for this device, and how does that affect its global availability?
The Pulmogine holds FDA 510(k) clearance (traditional route, classified under product code CAF) and MDD compliance, meaning it meets European medical device directives. The FDA route ensures U.S. market access via a premarket submission process, while MDD compliance facilitates availability in the European Economic Area. Clinicians should confirm local regulatory requirements, as MDD has since been replaced by MDR (Medical Device Regulation), which may impact future sales or use in Europe.
How portable is the Pulmogine, and are there any restrictions on its use in clinical environments like MRI rooms?
The Pulmogine is explicitly described as a handheld, portable device, making it suitable for both clinical and home use. However, there are no MRI safety restrictions noted in the provided data, which means it should not be assumed safe for use in MRI environments without additional manufacturer documentation or third-party testing. Clinicians should verify compatibility with their facility’s MRI protocols to avoid interference or safety hazards.
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: HCmed Innovations, 心誠鎂行動醫電 - hcmed-inno.com, Vibrating mesh nebulizer - Pulmogine™ - HCmed Innovations - for general ..., PDF HCMed Innovations Co., Ltd. Yiling Lee Supervisor, Regulatory Affairs ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K202171 | Class II | Active |
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Manufacturer
- Manufacturer
- Hcmed Innovations Co., Ltd.
Sources (2)
- FDA 510(k) K202171 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026