Panels › General Hospital › Product code FMW · Class 1
Cover, Mattress (Medical Purposes)
Regulation 880.6190
0510(k)s in 12 months (14 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in FMW
| Company | 510(k)s | Recalls |
|---|---|---|
| Invacare Corporation | 0 | 2 |
| Perfect Fit Industries, Inc. | 2 | 0 |
| Precision Fabrics Group, Inc. | 2 | 0 |
| Adroit Medical Systems, Inc. | 1 | 0 |
| Allergy Control Products, Inc. | 1 | 0 |
| Allergy Direct | 1 | 0 |
| American Threshold Industries, Inc. | 1 | 0 |
| Chase Mfg. Co. | 1 | 0 |
| Demite Limited | 1 | 0 |
| Mallinckrodt Group, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2014 | Primus Medical LLC Prime Care Transcend Mattress, Prime Care Transcend Perimeter Mattress, Prime Care Transcend Advanced Mattress, Prime Care Transcend Advanced Perimeter Mattress, Prime Plus Bariatric Mattress and Terminated |
FMW | None listed |
| Sep 12, 2010 | Invacare Corporation CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series of manual, semi-electric and electric beds.
Mattresses can be identified by looking on the law label tag for the fo Terminated |
FMW | None listed |
| Sep 12, 2010 | Invacare Corporation Mattress Model 5185 and 5185XL.
Manufactured by:
Invacare Corp., 2101 East Lake Mary Blvd., Sanford, FL 32773.
Mattress Model 5185 and 5185XL were packaged in the IVC Bed Models BED2-1633, BED4-16 Terminated |
FMW | None listed |
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