FMW — Cover, Mattress (Medical Purposes) Class I
FDA Device Classification
Classification Details
- Product Code
- FMW
- Device Class
- Class I
- Regulation Number
- 880.6190
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K152884 | precision fabrics group | DermaTherapy Bed Linens | June 20, 2016 |
| K061242 | precision fabrics group | DERMATHERAPY, MODEL 22216 | January 25, 2007 |
| K001003 | demite limited | Z-NET | December 10, 2001 |
| K992702 | allergy direct | EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PI | November 8, 1999 |
| K940327 | w.l. gore and associates | INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MAT | February 25, 1994 |
| K935220 | paladin medical | CORE PREVENT MATTRESS MODIFICATION | November 29, 1993 |
| K924807 | perfect fit industries | REUSABLE INCONTIENT UNDERPAD | February 10, 1993 |
| K924477 | perfect fit industries | WIPEABLE PILLOW | January 29, 1993 |
| K923173 | turnsoft | OBALON COVER | November 6, 1992 |
| K921928 | adroit medical systems | SOFT-COVER | November 6, 1992 |
| K903382 | allergy control products | ALLERGY CONTROL COVERS | November 2, 1990 |
| K902446 | mallinckrodt group | DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST | August 10, 1990 |
| K832483 | american threshold industries | MATTRESS COVER, ANTI-MICROBIAL | February 4, 1984 |
| K780033 | chase mfg | MATTRESSES, CONDUCTIVE & COVERS | February 21, 1978 |