Portable Oxygen Concentrator JAY-1000P
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243833 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)
The Portable Oxygen Concentrator JAY-1000P is a medical device classified as a Generator, Oxygen, Portable, designed to concentrate ambient air to deliver supplemental oxygen therapy. It operates by filtering and compressing atmospheric air to produce oxygen-enriched gas, suitable for patients requiring oxygen support in ambulatory or home settings.
The device is intended for single-use or reusable applications, depending on manufacturer guidelines, and is regulated under FDA 510(k) clearance (K243833) with a classification of Class II. It supports adjustable oxygen concentration (38%–93%) and includes DC power compatibility for automotive use, though MRI safety and sterility specifications are not detailed in the provided data. Storage and usage follow standard medical device protocols as outlined in the manufacturer’s instructions.
Frequently asked questions
How does the JAY-1000P Portable Oxygen Concentrator differ from traditional oxygen tanks in terms of oxygen delivery method?
The JAY-1000P Portable Oxygen Concentrator delivers oxygen by filtering and compressing ambient air to produce oxygen-enriched gas, rather than using pre-filled oxygen tanks. This allows it to continuously generate oxygen on-demand, making it ideal for patients who need long-term oxygen therapy in ambulatory or home settings without the need for refills.
Can the JAY-1000P be used in a car, and what power source does it require?
Yes, the JAY-1000P is designed with DC power compatibility, allowing it to operate using automotive power sources. This makes it suitable for use in vehicles, providing flexibility for patients who need oxygen therapy while traveling.
Is the JAY-1000P intended for single-use or reusable applications, and what does that mean for maintenance?
The JAY-1000P is designed for either single-use or reusable applications, depending on the manufacturer’s guidelines. If reusable, it requires proper cleaning, maintenance, and sterilization as outlined in the manufacturer’s instructions to ensure safe and effective operation. Single-use models would not require maintenance beyond initial setup.
What oxygen concentration range does the JAY-1000P provide, and how might this benefit patients?
The JAY-1000P delivers adjustable oxygen concentrations between 38% and 93%, allowing clinicians to tailor therapy to a patient’s specific needs. This flexibility is particularly useful for patients with varying oxygen requirements, such as those with chronic obstructive pulmonary disease (COPD) or other respiratory conditions.
How is the regulatory status of the JAY-1000P relevant to healthcare providers considering this device?
The JAY-1000P has received FDA 510(k) clearance (K243833) under the classification of Class II, indicating it meets regulatory standards for safety and effectiveness as a portable oxygen generator. This clearance was determined through a review by the FDA’s Anesthesiology Advisory Committee, ensuring it aligns with established medical device regulations for oxygen therapy devices.
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: Portable Oxygen Concentrator JAY-1000P-Longfian, Portable Oxygen Concentrator - LONGFIAN - longfiantech.com, JAY-1000 Portable Oxygen Concentrator - Halomedicals Systems - USA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243833 | Class II | Active |
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Manufacturer
- Manufacturer
- Longfian Scitech Co., Ltd.
Sources (1)
- FDA 510(k) K243833 24 fields · synced Sep 19, 2026