510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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FMWClass I

Cover, Mattress (Medical Purposes)

21 CFR 880.6190 / General Hospital
FDA source (opens on fda.gov)

FMW is the FDA product code for Cover, Mattress (Medical Purposes), a class I device type, regulated under 21 CFR 880.6190. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
FMW
Device name
Cover, Mattress (Medical Purposes)
Regulation
21 CFR 880.6190
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
14
Ingested recalls
3

Clearances, product code FMW

By decision year
14 clearances under product code FMW with a decision year between 1978 and 2016, 1993 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code FMW by decision year
YearClearances
19781
19841
19902
19922
19933
19941
19991
20011
20071
20161

Applicants with the most clearances

Product code FMW
Applicants holding the most 510(k) clearances under product code FMW
ApplicantClearances
Perfect Fit Industries, Inc.2
Precision Fabrics Group, Inc.2
Adroit Medical Systems, Inc.1
Allergy Control Products, Inc.1
Allergy Direct1
American Threshold Industries, Inc.1
Chase Mfg. Co.1
Demite Limited1
Mallinckrodt Group, Inc.1
Paladin Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 210 companies shown, in name order