510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
FMQClass I

Restraint, Protective

21 CFR 880.6760 / General Hospital
FDA source (opens on fda.gov)

FMQ is the FDA product code for Restraint, Protective, a class I device type, regulated under 21 CFR 880.6760. As of , FDA records hold 134 510(k) clearances under this code, the most recent dated , and 33 recalls.

Classification record

Product code
FMQ
Device name
Restraint, Protective
Regulation
21 CFR 880.6760
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
134
Ingested recalls
33

Clearances, product code FMQ

By decision year
134 clearances under product code FMQ with a decision year between 1976 and 2011, 1996 the highest year at 90.
Show the numbers
510(k) clearances under FDA product code FMQ by decision year
YearClearances
19761
19778
19781
19793
19801
19811
19851
19931
199690
199718
19981
19992
20013
20081
20091
20111

Applicants with the most clearances

Product code FMQ
Applicants holding the most 510(k) clearances under product code FMQ
ApplicantClearances
DeRoyal Industries, Inc.15
Heelbo, Inc.14
Skil-Care Corp.12
J. T. Posey Co.9
Tecnol Medical Products, Inc.9
Morrison Medical Products8
Medical Restraints, Inc.7
MEDLINE INDUSTRIES, LP - Northfield5
Fla Orthopedics, Inc.4
Hollister, Inc.4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 102 companies shown, in name order