FreeStyle Comfort
Portable Oxygen Concentrator, 1-5 LPM, Pulse Dose Setting, English Two Single Batteries
22manufacturers in China registered for this device type
6catalogue numbers in this listing
4510(k) clearances naming this product code
7recalls on this code
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 | Caire 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, Manufacturer |
| 510(k) | K020324 |
| Record published | 2020-08-06 |
| Record revised | 2020-04-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AS200-SW3 | In distribution | |
| AS200-1DTC | In distribution | |
| AS200-101 | In distribution | |
| AS200-201 | In distribution | |
| AS200-1R | In distribution | |
| AS200-1 | 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 |
|---|---|
| K250671 | 2025-07-11 |
| K120785 | 2012-10-25 |
| K121167 | 2012-05-02 |
| K952268 | 1995-08-11 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Caire Inc. | 510(k) number | 2024-10-04 | Class II | Nonconforming Material/Component | Potential failure of affected units to recharge the battery of the oxygen concentrators. | 739 concentrators | |
| Caire Inc. | 510(k) number | 2024-10-04 | Class II | Nonconforming Material/Component | Potential failure of affected units to recharge the battery of the oxygen concentrators. | 23 concentrators | |
| Oxus America, Inc. | 510(k) number | 2013-01-14 | Class II | Nonconforming Material/Component | Due to past battery inventory storage conditions and deficiencies in the maintenance procedure, it was possible that some batteries were over-discharged to point of damaging the cells. | 1724 total units | 2013-07-17 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-10-04 | Class II | Nonconforming Material/Component | Potential failure of affected units to recharge the battery of the oxygen concentrators. | 26 concentrators | |
| 2024-10-04 | Class II | Nonconforming Material/Component | Potential failure of affected units to recharge the battery of the oxygen concentrators. | 6 concentrators | |
| 2022-03-25 | Class II | No Marketing Application | The device was not cleared for U.S. distribution. | 2 oxygen concentrators | 2023-10-05 |
| 2019-11-21 | Class II | Packaging process control | Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US.. | 4 units | 2020-11-20 |
| 2019-09-16 | Class II | Nonconforming Material/Component | There is an electronics control issue that causes the unit to not power on with battery power only. | 10 units | 2020-12-16 |
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.