Rugged Oxygen Generator (ROG)
Rugged Oxygen Generator produces supplemental oxygen by a chemical reaction for individuals aged 17 and older. It is a single-use device for emergency, home or commercial settings,…
Rugged Oxygen Generator produces supplemental oxygen by a chemical reaction for individuals aged 17 and older. It is a single-use device for emergency, home or commercial settings, providing at least 90 liters over at least 15 minutes at a minimum flow of 6 liters per minute.
The generator delivers oxygen at at least 96% purity. An integrated friction initiator starts the reaction when its dial is turned, eliminating the need for a compressed oxygen cylinder.
Listed Item
The Rugged Oxygen Generator (ROG) is a chemical based portable oxygen generator which generates a minimum of 96% oxygen for at least 15 minutes at a flow rate of 6 litres per minute minimum. It is a is a self-contained device with the oxygen delivered via standard oxygen mask or nasal cannula.
Patient Connection
Oxygen is delivered through a standard oxygen mask. The mask and tubing are supplied by the user. The described configuration does not offer a nasal cannula and is intended for over-the-counter emergency or supplemental oxygen use.
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 | Molecular Products Ltd, United Kingdom |
|---|---|
| FDA product code | CAW |
| Device type | Generator, Oxygen, Portable |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5440 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K240561 |
| Record published | 2026-04-21 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -20 to 50 °C |
| Packaging | Box of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RO01-00001 | In distribution | |
| EO209P63N29 | In distribution |
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 |
| X-PLO2R | Belluscura, LLC | 17 |
| 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 |
Showing 12 of 187. All products under Generator, Oxygen, Portable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240561 | 2024-12-06 |
| K131016 | 2013-11-27 |
| K062153 | 2006-11-21 |
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.