X-PLO2R
X-PLOR Portable Oxygen Concentrator Pkg US - 2 Batteries - 5 Setting
22manufacturers in China registered for this device type
17catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Guangdong (5), Beijing (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foshan Kycare Medical Equipment Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 3 |
| Jakamed Instruments Co., Ltd. | Changsha | Hunan | Contract manufacturer | 2 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Jiangsu Yuyue Medical Equipment & Supply Company Limited | Jiangsu | Jiangsu | Contract manufacturer | 17 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Danyang Huayi Medical Supply & Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 11 |
| Shandong Moonlight Electronics Tech Co., Ltd. | Weifang | Shandong | Manufacturer | 11 |
| Honsun (Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 9 |
| Beijing Choicemmed Technology Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 9 |
| Foshan Care Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 3 |
| Zhengzhou Olive Electronic Technology Co., Ltd. | Zhengzhou | Henan | Manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Generator, Oxygen, Portable
Record
| Listed by | Belluscura, LLC, United States |
|---|---|
| FDA product code | CAW |
| Device type | Generator, Oxygen, Portable |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5440 |
| 510(k) | K203086 |
| Record published | 2025-04-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | expiry date, manufacturing date, serial number |
| Distribution end date | 2025-04-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 50051-HK-001 | In distribution | |
| 50188 | In distribution | |
| 50051-1 | In distribution | |
| 50073 | In distribution | |
| 50073 | In distribution | |
| 50051-US-003 | In distribution | |
| 52291 | In distribution | |
| 50051-US-001 | In distribution | |
| 50084 | In distribution | |
| 52051-US-001 | In distribution | |
| 52191 | In distribution | |
| 50351 | In distribution | |
| 50051-1-RE | In distribution | |
| 50051-US-002-RE | In distribution | |
| 50051-US-001-RE | In distribution | |
| 50051-US-002 | In distribution | |
| 52051-US-002 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeVilbiss | DeVilbiss Healthcare LLC. | 50 |
| EverFlo | Respironics Inc. | 32 |
| Mark 5 Nuvo Lite | Nidek Medical Products, Inc. | 30 |
| SimplyGo Mini | Respironics Inc. | 26 |
| Mark 5 Nuvo 8 | Nidek Medical Products, Inc. | 12 |
| ViveBreathe | Vive Health LLC | 11 |
| Invacare® HomeFill® Oxygen System | Invacare GmbH | 11 |
| Discov-R | Belluscura, LLC | 11 |
| NewLife Elite | Caire Inc. | 10 |
| NewLife Elite | Airsep Corp. | 10 |
| Rhythm Healthcare | Qingdao Kingon Medical Science AND Technology Co., Ltd. | 9 |
| OxyGo | Mv Life, LLC | 9 |
Showing 12 of 187. All products under Generator, Oxygen, Portable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203086 | 2021-03-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.