FMQ · Class I · 21 CFR 880.6760

FDA Product Code FMQ: Restraint, Protective

Leading manufacturers include Deroyal Industries, Inc., Heelbo, Inc. and Skil-Care Corp..

134
Total
134
Cleared
74d
Avg days
1976
Since
134 devices
25–48 of 134
Cleared Jan 03, 1997
ROLL BELTS
K963467
Deroyal Industries, Inc.
General Hospital · 122d
Cleared Dec 19, 1996
PELVIC HOLDER
K963465
Deroyal Industries, Inc.
General Hospital · 107d
Cleared Dec 02, 1996
THE WRAP IMMOBILIZATION SYSTEM
K963547
Safe Restraints, Inc.
General Hospital · 88d
Cleared Dec 02, 1996
PATIENT RESTRAINTS
K963906
Safety Intl., Inc.
General Hospital · 63d
Cleared Nov 22, 1996
POSEY STRAIGHT JACKETS
K963410
J. T. Posey Co.
General Hospital · 84d
Cleared Nov 22, 1996
MULTIPLE BELTS
K963414
J. T. Posey Co.
General Hospital · 84d
Cleared Nov 22, 1996
PROTECTIVE RESTRAINT (WAIST HOLDER)
K963421
Kenad SG Medical, Inc.
General Hospital · 84d
Cleared Nov 22, 1996
PROTECTIVE RESTRAINT (PROTECTIVE MITT)
K963422
Kenad SG Medical, Inc.
General Hospital · 84d
Cleared Nov 22, 1996
PROTECTIVE RESTRAINT (VEST RESTRAINT)
K963430
Kenad SG Medical, Inc.
General Hospital · 84d
Cleared Nov 22, 1996
RESTRAINT ACCESSORIES
K963436
J. T. Posey Co.
General Hospital · 84d
Cleared Nov 22, 1996
JACKETS AND VESTS
K963442
J. T. Posey Co.
General Hospital · 84d
Cleared Nov 22, 1996
SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RESRAINT,NYON LIMB HOLDER,VINYL LIMB HOLDER,NYLON BED RESTRAINS
K963485
Humane Restraint, Inc.
General Hospital · 80d
Cleared Nov 22, 1996
QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)
K963552
Tecnol Medical Products, Inc.
General Hospital · 78d
Cleared Nov 22, 1996
WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)
K963559
Tecnol Medical Products, Inc.
General Hospital · 78d
Cleared Nov 22, 1996
PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)
K963564
Tecnol Medical Products, Inc.
General Hospital · 78d
Cleared Nov 21, 1996
COMFOR FOAM LIMB HOLDERS- SINGLE STRAP
K963462
Bird & Cronin, Inc.
General Hospital · 79d
Cleared Nov 21, 1996
24448-010 SECURE-ALL FINGER CONTROL MITT
K963554
Tecnol Medical Products, Inc.
General Hospital · 77d
Cleared Nov 21, 1996
SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030)
K963556
Tecnol Medical Products, Inc.
General Hospital · 77d
Cleared Nov 21, 1996
SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030
K963557
Tecnol Medical Products, Inc.
General Hospital · 77d
Cleared Nov 21, 1996
ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040)
K963561
Tecnol Medical Products, Inc.
General Hospital · 77d
Cleared Nov 21, 1996
ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145)
K963563
Tecnol Medical Products, Inc.
General Hospital · 77d
Cleared Nov 21, 1996
24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT
K963773
Tecnol Medical Products, Inc.
General Hospital · 63d
Cleared Nov 19, 1996
POSEY LAPTOP TRAYS
K963411
J. T. Posey Co.
General Hospital · 81d
Cleared Nov 19, 1996
PELVIC HOLDERS
K963437
J. T. Posey Co.
General Hospital · 81d