Invacare® HomeFill® Oxygen System
11 catalogue numbers from HF2PCL6, listed by Invacare GmbH, Germany, under Generator, Oxygen, Portable. 22 manufacturers in China are registered for this product code.
22manufacturers in China registered for this device type
11catalogue numbers in this listing
20510(k) clearances naming this product code
4recalls 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 | Invacare GmbH, Germany |
|---|---|
| FDA product code | CAW |
| Device type | Generator, Oxygen, Portable |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5440 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-09-14 |
| Record revised | 2023-09-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 140 °F; Handling environment temperature -40 to 140 °F |
| Distribution end date | 2022-11-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HF2PCL6 | Withdrawn | |
| IOH2MD | Withdrawn | |
| HF2PCL4 | Withdrawn | |
| HF2POST9 | Withdrawn | |
| HF2POST6 | Withdrawn | |
| IOH200 | Withdrawn | |
| HF2PC9 | Withdrawn | |
| IOH200C | Withdrawn | |
| HF2PCM2KIT | Withdrawn | |
| HF2POSTD | Withdrawn | |
| HF2POSTD81 | 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 |
| X-PLO2R | Belluscura, LLC | 17 |
| Mark 5 Nuvo 8 | Nidek Medical Products, Inc. | 12 |
| ViveBreathe | Vive Health LLC | 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 |
|---|---|
| K203210 | 2021-04-12 |
| K200890 | 2020-08-06 |
| K191159 | 2019-08-29 |
| K160630 | 2016-09-27 |
| K083751 | 2009-05-21 |
| K071928 | 2007-12-12 |
| K021685 | 2002-07-23 |
| K020386 | 2002-07-02 |
| K003939 | 2001-03-21 |
| K983627 | 1999-10-22 |
| K983777 | 1998-12-18 |
| K924818 | 1993-08-06 |
| K914488 | 1992-09-15 |
| K904087 | 1990-10-26 |
| K891488 | 1989-05-25 |
| K851435 | 1985-07-29 |
| K851434 | 1985-07-29 |
| K851437 | 1985-07-29 |
| K851439 | 1985-07-29 |
| K851438 | 1985-07-29 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-06-10 | Class III | Labeling Change Control | Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the “Rx Only” statement as required. | 179 devices | |
| 2020-10-30 | Class II | Device Design | Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure that can result in self-extinguishing fires or cap explosions. | 384,767 units | 2024-12-31 |
| 2014-10-31 | Class II | Device Design | The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard. | 138,446 units distributed globally | 2017-02-07 |
| 2014-09-23 | Class II | Process control | It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and muffler causing a reduction in oxygen concentration. | 5,963 | 2015-06-18 |
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.