Identifiers
- 510(k) Number
- K230969 FDA 510(k)
- FDA Product Code
- CAW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5440 FDA 510(k)
- Regulation Number
- 868.5440 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a portable oxygen generator (Class II), designed to concentrate ambient air and deliver high-flow oxygen therapy. It operates by filtering and compressing atmospheric air to produce oxygen-enriched gas, typically at concentrations of 90% or higher, for patients requiring supplemental oxygen. The device is intended for use in clinical and home settings to support respiratory needs without the need for liquid or compressed gas cylinders.
The oxygen concentrator is supplied as a reusable medical device, intended for use in environments where electrical power is available. It is not classified as sterile and must be cleaned and maintained according to manufacturer guidelines to ensure proper function and hygiene. The device is regulated under FDA 510(k) clearance (K230969) and falls under the regulatory category 868.5440. It is designed for portable use, though specific MRI safety information is not provided in the available data.
Frequently asked questions
What is the Jiangsu Jumao Portable Oxygen Concentrator used for?
This device is designed to concentrate ambient air and deliver high-flow oxygen therapy, typically at concentrations of 90% or higher. It supports patients requiring supplemental oxygen in both clinical and home settings, eliminating the need for liquid or compressed gas cylinders. The portable design makes it suitable for environments where mobility is important, such as patient homes or outpatient care.
Is the Jiangsu Jumao Portable Oxygen Concentrator single-use or reusable?
The device is explicitly classified as a reusable medical device. It is not intended for single-use and must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper function and hygiene. Regular maintenance is essential to prevent contamination and ensure reliable performance.
Does the Jiangsu Jumao Portable Oxygen Concentrator require sterilization?
No, the device is not classified as sterile. It is designed for reusable use in environments where electrical power is available. Sterilization is not applicable, but thorough cleaning and maintenance are required to uphold hygiene standards and operational integrity.
What regulatory approval does the Jiangsu Jumao Portable Oxygen Concentrator hold?
The device holds FDA 510(k) clearance under the reference number K230969. It is categorized under the regulatory product code 868.5440 and falls under the classification of a Class II medical device. The clearance was granted by the FDA’s Anesthesiology Advisory Committee, confirming its substantial equivalence to predicate devices.
How is the Jiangsu Jumao Portable Oxygen Concentrator powered, and what are its limitations?
The device operates using electrical power, making it suitable for environments where a power source is available. It is designed for portable use, though specific MRI safety information is not provided in the available data. Users should ensure compatibility with their facility’s electrical infrastructure and follow manufacturer guidelines for safe operation.
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: Transport Wheelchair, Oxygen Machine - Jumao, Jiangsu Jumao X-Care Medical Equipment Co., Ltd., kwjindex - Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230969 | Class II | Active |
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Manufacturer
- Manufacturer
- Jiangsu Jumao X-Care Medical Equipment Co., Ltd
- FDA Applicant
- Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
Sources (1)
- FDA 510(k) K230969 24 fields · synced Oct 6, 2026