Product code FMW
- Device name
- Cover, Mattress (Medical Purposes)
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.6190
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152884 | DermaTherapy Bed Linens | Precision Fabrics Group, Inc. | 2016-06-20 |
| K061242 | DERMATHERAPY, MODEL 22216 | Precision Fabrics Group, Inc. | 2007-01-25 |
| K001003 | Z-NET | Demite Limited | 2001-12-10 |
| K992702 | EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM | Allergy Direct | 1999-11-08 |
| K940327 | INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW | W. L. Gore & Associates, Inc. | 1994-02-25 |
| K935220 | CORE PREVENT MATTRESS MODIFICATION | Paladin Medical, Inc. | 1993-11-29 |
| K924807 | REUSABLE INCONTIENT UNDERPAD | Perfect Fit Industries, Inc. | 1993-02-10 |
| K924477 | WIPEABLE PILLOW | Perfect Fit Industries, Inc. | 1993-01-29 |
| K921928 | SOFT-COVER | Adroit Medical Systems, Inc. | 1992-11-06 |
| K923173 | OBALON COVER | Turnsoft, Inc. | 1992-11-06 |
| K903382 | ALLERGY CONTROL COVERS | Allergy Control Products, Inc. | 1990-11-02 |
| K902446 | DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST | Mallinckrodt Group, Inc. | 1990-08-10 |
| K832483 | MATTRESS COVER, ANTI-MICROBIAL | American Threshold Industries, Inc. | 1984-02-04 |
| K780033 | MATTRESSES, CONDUCTIVE & COVERS | Chase Mfg. Co. | 1978-02-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 16931918177113 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2023-07-20 |
| 16931918119458 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2022-11-27 |
| 16931918155050 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2022-11-27 |
| 16931918197586 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2022-11-23 |
| 16931918143590 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2022-11-23 |
| 16931918139364 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2022-11-23 |
| 16931918138701 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2022-11-23 |
| 16931918133959 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2022-11-23 |
| 16931918116662 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2022-11-23 |
| 16931918115313 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2022-11-23 |
| 16931918152752 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2022-11-23 |
| 16931918155395 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2022-11-23 |
| 16931918158099 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2022-11-23 |
| 16931918158853 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2022-11-23 |
| 16931918172354 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2022-11-23 |
| 16931918177182 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2022-11-23 |
| 16931918183411 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2022-11-23 |
| 10810050244845 | NA | DOMICO MED-DEVICE, LLC | 2021-10-07 |
| 00616784816135 | Pillow Cases, Tissue / Poly 2-ply, 21" x 30", White | Dynarex Corporation | 2021-09-01 |
| 16931918131450 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2021-02-27 |
| 16931918112107 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2021-02-27 |
| 10810050242698 | N/A | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 10810050242681 | NA | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 10810050242674 | N/A | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 10810050242667 | NA | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 10810050242650 | N/A | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 10810050242643 | NA | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 10810050242636 | N/A | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 10810050242629 | NA | DOMICO MED-DEVICE, LLC | 2020-08-14 |
| 10810050242612 | NA | DOMICO MED-DEVICE, LLC | 2020-08-14 |