FMW · Class I · 21 CFR 880.6190

FDA Product Code FMW: Cover, Mattress (medical Purposes)

Leading manufacturers include Precision Fabrics Group, Inc., Perfect Fit Industries, Inc. and Demite Limited.

14
Total
14
Cleared
168d
Avg days
1978
Since

FDA 510(k) Cleared Cover, Mattress (medical Purposes) Devices (Product Code FMW)

14 devices
1–14 of 14
Cleared Jun 20, 2016
DermaTherapy Bed Linens
K152884
Precision Fabrics Group, Inc.
General Hospital · 264d
Cleared Jan 25, 2007
DERMATHERAPY, MODEL 22216
K061242
Precision Fabrics Group, Inc.
General Hospital · 267d
Cleared Dec 10, 2001
Z-NET
K001003
Demite Limited
General Hospital · 621d
Cleared Nov 08, 1999
EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM
K992702
Allergy Direct
General Hospital · 88d
Cleared Feb 25, 1994
INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW
K940327
W.L. Gore & Associates, Inc.
General Hospital · 32d
Cleared Nov 29, 1993
CORE PREVENT MATTRESS MODIFICATION
K935220
Paladin Medical, Inc.
General Hospital · 48d
Cleared Feb 10, 1993
REUSABLE INCONTIENT UNDERPAD
K924807
Perfect Fit Industries, Inc.
General Hospital · 160d
Cleared Jan 29, 1993
WIPEABLE PILLOW
K924477
Perfect Fit Industries, Inc.
General Hospital · 148d
Cleared Nov 06, 1992
SOFT-COVER
K921928
Adroit Medical Systems, Inc.
General Hospital · 196d
Cleared Nov 06, 1992
OBALON COVER
K923173
Turnsoft, Inc.
General Hospital · 129d
Cleared Nov 02, 1990
ALLERGY CONTROL COVERS
K903382
Allergy Control Products, Inc.
General Hospital · 98d
Cleared Aug 10, 1990
DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST
K902446
Mallinckrodt Group, Inc.
General Hospital · 70d
Cleared Feb 04, 1984
MATTRESS COVER, ANTI-MICROBIAL
K832483
American Threshold Industries, Inc.
General Hospital · 194d
Cleared Feb 21, 1978
MATTRESSES, CONDUCTIVE & COVERS
K780033
Chase Mfg. Co.
General Hospital · 43d

About Product Code FMW - Regulatory Context