SimplyGo Mini
SimplyGo Mini Portable Oxygen Concentrator (with Standard Battery), Brazil
22manufacturers in China registered for this device type
26catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
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 | Respironics Inc., United States |
|---|---|
| FDA product code | CAW |
| Device type | Generator, Oxygen, Portable |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5440 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-09-10 |
| Record revised | 2023-02-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment humidity 15 to 93 % RH |
| Distribution end date | 2021-03-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SimplyGo Mini, Extended Battery, Argentina | In distribution | |
| SimplyGo Mini, US | In distribution | |
| SimplyGo Mini, INTL | In distribution | |
| SimplyGo Mini with Extended Battery, IT | In distribution | |
| SimplyGo Mini with Standard Battery, IKK | In distribution | |
| SimplyGo Mini with Extended Battery, IKK | In distribution | |
| SimplyGo Mini with Standard Battery, US | In distribution | |
| SimplyGo Mini, IKK | In distribution | |
| SimplyGo Mini with 2 Standard Batteries, US | In distribution | |
| SimplyGo Mini, Standard Battery, Argentina | In distribution | |
| SimplyGo Mini with Standard Battery, INTL | In distribution | |
| 00 | In distribution | |
| SimplyGo Mini with Extended Battery, US | In distribution | |
| SimplyGo Mini with Extended Battery, INTL | In distribution | |
| SimplyGo Mini with Standard Battery, IT | In distribution | |
| SimplyGo Mini with Standard Battery, SA | Withdrawn | |
| SimplyGo Mini, JP | Withdrawn | |
| SimplyGo Mini with Extended Battery, BR | Withdrawn | |
| SimplyGo Mini, SA | Withdrawn | |
| SimplyGo Mini with Extended Battery, SA | Withdrawn | |
| SimplyGo Mini, KR | Withdrawn | |
| SimplyGo Mini with Standard Battery, KR | Withdrawn | |
| SimplyGo Mini with Standard Battery, BR | Withdrawn | |
| SimplyGo Mini, Standard Battery, JP | Withdrawn | |
| SimplyGo Mini, BR | Withdrawn | |
| SimplyGo Mini with Extended Battery, KR | 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 |
| 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 |
| OxyGo | Mv Life, LLC | 9 |
Showing 12 of 187. All products under Generator, Oxygen, Portable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111885 | 2011-11-04 |
| K091028 | 2009-07-23 |
| K081206 | 2008-07-28 |
| K061261 | 2006-06-28 |
| K043006 | 2005-02-11 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Respironics Inc. | UDI-DI | 2025-10-07 | Class II | Nonconforming Material/Component | Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running | 56 units (55 US, 1 OUS) |
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.