Owgels Oxygen Concentrator
by Guangzhou Life Light Electronic Technology Co., Ltd. EUDAMED510(k)
Active
510(k) K191875
Overview
The Owgels Oxygen Concentrator is a portable medical device classified as an oxygen generator. It extracts oxygen from ambient air and delivers it at a controlled flow rate, designed for use in clinical and home settings to provide supplemental oxygen therapy.
This device is supplied as a reusable medical instrument and is intended for use in environments where oxygen supply infrastructure is limited. It operates on standard electrical power and is not classified as MRI-safe. The device is authorized under FDA 510K clearance and complies with the Medical Device Directive (MDD). Multiple registration numbers and FEI numbers are associated with its regulatory submissions, reflecting its classification under device code CAW and regulation number 868.5440.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK191875 | Date20 Jul 2020 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CAW
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5440
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Guangzhou Life Light Electronic Technology Co., Ltd.
Questions
Is the Owgels Oxygen Concentrator designed for single-use or can it be reused in clinical settings?
The Owgels Oxygen Concentrator is explicitly described as a reusable medical instrument, meaning it is intended for repeated use in clinical or home settings. Since it is not classified as a single-use device, proper cleaning, maintenance, and adherence to manufacturer guidelines are required to ensure safe and effective operation over multiple uses.
What types of environments is the Owgels Oxygen Concentrator intended for, and how does it differ from traditional oxygen supply systems?
The Owgels Oxygen Concentrator is designed for clinical and home settings where oxygen supply infrastructure is limited. Unlike traditional oxygen tanks or cylinders, it generates oxygen on-demand by extracting it from ambient air, eliminating the need for bulky gas cylinders. This makes it particularly useful in areas with unreliable or inaccessible oxygen delivery systems.
Does the Owgels Oxygen Concentrator require any special handling or storage conditions?
The device data does not specify storage conditions, but as a reusable medical instrument, it should be stored in a clean, dry environment to prevent contamination or damage. Since it operates on standard electrical power, it should also be kept away from sources of moisture or extreme temperatures that could affect its performance or safety.
What regulatory pathways has the Owgels Oxygen Concentrator followed, and which agencies have authorized its use?
The Owgels Oxygen Concentrator has been authorized through FDA 510K clearance and complies with the Medical Device Directive (MDD) in Europe. It is classified under device code CAW and regulation number 868.5440, reflecting its status as a portable oxygen generator. The device was reviewed by the FDA’s Anesthesiology Advisory Committee (AN) and is listed under multiple registration numbers and FEI numbers in the FDA database.
Can the Owgels Oxygen Concentrator be used in an MRI environment, or does it pose any safety concerns in such settings?
The device is explicitly not classified as MRI-safe, meaning it should not be used in or near MRI environments. The presence of electronic components or materials could interfere with MRI imaging or pose safety risks to patients or staff. Always verify compatibility with MRI protocols before use in such settings.