Invacare Essentials
Replacement Cover for SES1080B42
89manufacturers in China registered for this device type
4catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Zhejiang (23), Jiangsu (20), Guangdong (12). 15 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Jiangsu Keling Medical Appliances Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 23 |
| Jiangyin Huashi Medical Equipment Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 21 |
| Dongguan China Effort Healthcare Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Changzhou Care-DE Sanitary Material Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Hubei Haixin Protective Products Group Co., Ltd. | Songzi | Hubei | Contract manufacturer | 10 |
| Shenzhen Lantise Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Changzhou Hongtai Paper Film Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Suzhou Baili Medical Supplies Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Jiangsu Hanfang Textile Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 8 |
| Jinhua Yueer ART Craft Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 6 |
| Haining Yikang Textile Co., Ltd. | Haining | Zhejiang | Contract manufacturer | 5 |
Showing 12 of 89. All 89 manufacturers in China registered for Cover, Mattress (Medical Purposes)
Record
| Listed by | Invacare GmbH, Germany |
|---|---|
| FDA product code | FMW |
| Device type | Cover, Mattress (Medical Purposes) |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6190 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-06-03 |
| Record revised | 2026-02-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60126513 | In distribution | |
| 60126512 | In distribution | |
| 60126514 | In distribution | |
| 60126515 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| C-Matt | Casco Manufacturing Solutions, Inc. | 171 |
| Underpad Quilted Ibex | Standard Textile Co., Inc. | 68 |
| Cmatt | Casco Manufacturing Solutions, Inc. | 43 |
| Casco | Casco Manufacturing Solutions, Inc. | 35 |
| Underpad Quilted | Standard Textile Co., Inc. | 29 |
| SelectAir | Moxi Enterprises, LLC | 28 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 20 |
| Drivemedical | Drive DeVilbiss Healthcare | 19 |
| Underpad Integrity | Standard Textile Co., Inc. | 18 |
| CT Gantry Cover | Pearl Inc. | 16 |
| ProtectYou2 | Moxi Enterprises, LLC | 13 |
| Excel Plus Comply Quilted PAD | Standard Textile Co., Inc. | 12 |
Showing 12 of 244. All products under Cover, Mattress (Medical Purposes)
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-10-11 | Not classified | Device Design | In October 2007 Invacare Corporation, Florida recalled CareGuard Mattresses, Models CG10180 and CG10180A, associated with IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the ValueCare Bed Series Semi Electric Beds, | 19143 | 2015-06-08 |
| 2007-08-29 | Not classified | Device Design | In September 2007 Invacare Corporation recalled the innerspring mattresses associated with Invacare’s IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the ValueCare Bed Series Semi Electric Bed. These mattresses we | 4896 | 2010-09-13 |
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.