Portable Mesh Nebulizer JM821
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Portable Mesh Nebulizer EUDAMED
- Device Name
- Portable Mesh Nebulizer EUDAMED
- Model / Reference
- JM802,JM810, JM811,JM817, JM818,JM821,JM822,JM827, JM828,JM829, JM830,JM832,JM833, JM835,JM836, JM837, JM838,JM839, JM841, JM842,JM843,JM888 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972433810157 EUDAMED06972433811024 EUDAMED06972433810263 EUDAMED06972433810041 EUDAMED06972433811048 EUDAMED06972433811086 EUDAMED06972433810256 EUDAMED06972433811239 EUDAMED06972433810195 EUDAMED06972433810072 EUDAMED06972433811222 EUDAMED06972433810065 EUDAMED06972433811147 EUDAMED06972433810225 EUDAMED06972433811093 EUDAMED06972433810102 EUDAMED06972433810171 EUDAMED06972433811109 EUDAMED06972433810133 EUDAMED06972433811116 EUDAMED
- Basic UDI-DI
- 697243381JM821EQ EUDAMED
- Direct Marketing DI
- 06972433810157 EUDAMED06972433811024 EUDAMED06972433810263 EUDAMED06972433810041 EUDAMED06972433811048 EUDAMED06972433811086 EUDAMED06972433810256 EUDAMED06972433811239 EUDAMED06972433810195 EUDAMED06972433810072 EUDAMED06972433811222 EUDAMED06972433810065 EUDAMED06972433811147 EUDAMED06972433810225 EUDAMED06972433811093 EUDAMED06972433810102 EUDAMED06972433810171 EUDAMED06972433810133 EUDAMED
- 510(k) Number
- K244035 FDA 510(k)
- FDA Product Code
- CAF FDA 510(k)
- EMDN Code
- Z12040210 ULTRASONIC NEBULISERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5630 FDA 510(k)
- Regulation Number
- 868.5630 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Portable Mesh Nebulizer JM821 is a mesh nebulizer, a device designed to convert liquid medication into a fine aerosol mist for inhalation therapy. It operates via a vibrating mesh technology to deliver precise, particle-sized droplets directly to the respiratory tract, facilitating efficient drug administration for conditions requiring aerosolized treatment.
This device is intended for portable use and is classified under the FDA Product Code CAF (Anesthesiology and Respiratory Devices). It is supplied as a single-use device, with no indication of sterility requirements beyond standard medical device handling. The JM821 is authorized under FDA 510K clearance and MDR compliance, ensuring regulatory adherence for clinical and home-use settings. No MRI safety information is provided.
Frequently asked questions
What is the primary purpose of the Portable Mesh Nebulizer (JM821) and how does it differ from traditional nebulizers?
The Portable Mesh Nebulizer (JM821) is designed to convert liquid medication into a fine aerosol mist for inhalation therapy, targeting precise delivery to the respiratory tract. Unlike traditional nebulizers, it uses vibrating mesh technology to generate smaller, more uniform particles, which can improve efficiency and reduce treatment time for conditions requiring aerosolized medication.
Is the JM821 intended for reusable or single-use applications, and what does that mean for maintenance?
The JM821 is explicitly labeled as a single-use device, meaning it is not meant to be reused after one treatment session. This design eliminates the need for cleaning or sterilization between uses, simplifying workflows in clinical or home settings while ensuring patient safety and hygiene.
What regulatory pathways has the JM821 followed, and what does that mean for its clinical use?
The JM821 has undergone FDA 510(k) clearance and MDR compliance, confirming it meets regulatory standards for safety and performance. This clearance allows its use in both clinical and home-care settings in the U.S. and EU, ensuring adherence to strict manufacturing and quality controls for medical devices.
Are there different sizes or models of the JM821, or is it a single unified device?
The provided data does not specify multiple sizes or models for the JM821—it is described as a single portable mesh nebulizer model. If variability exists (e.g., flow rates, battery life, or accessories), it would require additional documentation not included here.
How should the JM821 be stored, and are there any special handling requirements?
While the data does not specify exact storage conditions, as a single-use medical device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve functionality. Standard medical device handling (e.g., avoiding contamination) applies until 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 | K244035 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Jermei Medical Device Technology Co., Ltd.
Sources (21)
- FDA 510(k) K244035 24 fields · synced Sep 18, 2026
- EUDAMED 2b04faac-d0aa-4204-a9df-868510b567e6 61 fields · synced Jul 9, 2026
- EUDAMED ef2325df-be5e-4ac2-9816-1c9c5dfef109 61 fields · synced Jul 10, 2026
- EUDAMED d66228a1-8210-48b9-8046-a8381cb0a2e7 61 fields · synced Jul 11, 2026
- EUDAMED b7c294de-78d7-44d9-a7f3-56481f382dbf 61 fields · synced Jul 12, 2026
- EUDAMED e1f1342d-9858-47c9-bfb8-30682167300a 61 fields · synced Jul 13, 2026
- EUDAMED 73e6b0c7-0c45-477e-9f10-65999cc16608 61 fields · synced Jul 13, 2026
- EUDAMED ffc9e3b1-3e7b-4d19-a57f-5f9c643e52cc 61 fields · synced Jul 14, 2026
- EUDAMED 7243036e-460c-4e46-9bcd-581e6d6e0294 61 fields · synced Jul 14, 2026
- EUDAMED 69d2adf4-2a45-4567-be5a-ec972a57e51e 61 fields · synced Jul 17, 2026
- EUDAMED 3de9ee98-9413-4cc4-a16a-d341c1bb241e 61 fields · synced Jul 17, 2026
- EUDAMED a6c69f01-5a1f-442c-aaef-c61eaecf4db5 61 fields · synced Jul 18, 2026
- EUDAMED ec16c443-58e9-4942-a169-3c36409c159d 61 fields · synced Jul 19, 2026
- EUDAMED 31884b0e-27c0-40d4-b5b8-e0cff18cb0e6 61 fields · synced Jul 22, 2026
- EUDAMED fa6e51b0-05f8-4afd-9e44-f3f67edb4840 61 fields · synced Jul 25, 2026
- EUDAMED aa789a12-41b9-46b6-9c30-2c1f0d53bf73 61 fields · synced Jul 27, 2026
- EUDAMED b94477d1-05d5-46f9-a84f-a1983271b752 61 fields · synced Jul 28, 2026
- EUDAMED 3b9944e4-62bb-4fd0-988b-754c1fa43c34 61 fields · synced Jul 29, 2026
- EUDAMED 267b01c0-a23a-4f90-af46-1acc12555109 61 fields · synced Jul 30, 2026
- EUDAMED b541cc55-81ea-4cdb-8bda-249360cef7ad 61 fields · synced Aug 1, 2026
- EUDAMED 545b3afb-9bea-44df-b845-c0fefd55c618 61 fields · synced Aug 2, 2026