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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 20, 2016 | K152884 | DermaTherapy Bed Linens Precision Fabrics Group, Inc. | FMW |
| Jan 25, 2007 | K061242 | DERMATHERAPY, MODEL 22216 Precision Fabrics Group, Inc. | FMW |
| Dec 10, 2001 | K001003 | Z-NET Demite Limited | FMW |
| Nov 8, 1999 | K992702 | EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM Allergy Direct | FMW |
| Feb 25, 1994 | K940327 | INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW W. L. Gore & Associates, Inc. | FMW |
| Nov 29, 1993 | K935220 | CORE PREVENT MATTRESS MODIFICATION Paladin Medical, Inc. | FMW |
| Feb 10, 1993 | K924807 | REUSABLE INCONTIENT UNDERPAD Perfect Fit Industries, Inc. | FMW |
| Jan 29, 1993 | K924477 | WIPEABLE PILLOW Perfect Fit Industries, Inc. | FMW |
| Nov 6, 1992 | K923173 | OBALON COVER Turnsoft, Inc. | FMW |
| Nov 6, 1992 | K921928 | SOFT-COVER Adroit Medical Systems, Inc. | FMW |
| Nov 2, 1990 | K903382 | ALLERGY CONTROL COVERS Allergy Control Products, Inc. | FMW |
| Aug 10, 1990 | K902446 | DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST Mallinckrodt Group, Inc. | FMW |
| Feb 4, 1984 | K832483 | MATTRESS COVER, ANTI-MICROBIAL American Threshold Industries, Inc. | FMW |
| Feb 21, 1978 | K780033 | MATTRESSES, CONDUCTIVE & COVERS Chase Mfg. Co. | FMW |
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