FMW · Cover, Mattress (Medical Purposes)
General Hospital · 21 CFR 880.6190 · Class 1
Overview
| Product Code | FMW |
|---|---|
| Device Name | Cover, Mattress (Medical Purposes) |
| Regulation | 21 CFR 880.6190 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A mattress cover for medical purposes is a device intended for medical purposes that is used to protect a mattress. It may be electrically conductive or contain a germicide.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K152884 | DermaTherapy Bed Linens | Precision Fabrics Group, Inc. | Jun 20, 2016 | SESE |
| K061242 | DERMATHERAPY, MODEL 22216 | Precision Fabrics Group, Inc. | Jan 25, 2007 | SESE |
| K001003 | Z-NET | Demite Limited | Dec 10, 2001 | SESE |
| K992702 | EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM | Allergy Direct | Nov 8, 1999 | SESE |
| K940327 | INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW | W. L. Gore & Associates, Inc. | Feb 25, 1994 | SESE |
| K935220 | CORE PREVENT MATTRESS MODIFICATION | Paladin Medical, Inc. | Nov 29, 1993 | SESE |
| K924807 | REUSABLE INCONTIENT UNDERPAD | Perfect Fit Industries, Inc. | Feb 10, 1993 | SESE |
| K924477 | WIPEABLE PILLOW | Perfect Fit Industries, Inc. | Jan 29, 1993 | SESE |
| K923173 | OBALON COVER | Turnsoft, Inc. | Nov 6, 1992 | SESE |
| K921928 | SOFT-COVER | Adroit Medical Systems, Inc. | Nov 6, 1992 | SESE |
| K903382 | ALLERGY CONTROL COVERS | Allergy Control Products, Inc. | Nov 2, 1990 | SESE |
| K902446 | DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST | Mallinckrodt Group, Inc. | Aug 10, 1990 | SESE |
| K832483 | MATTRESS COVER, ANTI-MICROBIAL | American Threshold Industries, Inc. | Feb 4, 1984 | SESE |
| K780033 | MATTRESSES, CONDUCTIVE & COVERS | Chase Mfg. Co. | Feb 21, 1978 | SESE |
Top Applicants
- Perfect Fit Industries, Inc. — 2 clearances
- Precision Fabrics Group, Inc. — 2 clearances
- Adroit Medical Systems, Inc. — 1 clearance
- Allergy Control Products, Inc. — 1 clearance
- Allergy Direct — 1 clearance
