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
73–96 of 134
Cleared Nov 06, 1996
POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER
K963431
Zimmer, Inc.
General Hospital · 68d
Cleared Nov 06, 1996
ECONOMY SAFETY VEST RESTRAINT, SHOULDER TIE SAFETY VEST/SAFETY VEST RESTRAINT, HEAVY DUTY VEST RESTRAINT, MESH SAFETY VE
K963435
Zimmer Patient Care Division
General Hospital · 68d
Cleared Nov 06, 1996
MORRISON MEDICAL DISPOSABLE RESTRAINT STRAP
K963494
Morrison Medical Products
General Hospital · 64d
Cleared Nov 04, 1996
HEELBO SECURITY BELT
K963060
Heelbo, Inc.
General Hospital · 89d
Cleared Nov 01, 1996
HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET
K963099
Heelbo, Inc.
General Hospital · 84d
Cleared Nov 01, 1996
HEELBO PELVIC RESTRAINT
K963199
Hollister, Inc.
General Hospital · 78d
Cleared Oct 31, 1996
HEELBO LIFE JACKET WITH CROTCH SUPPORT
K963041
Heelbo, Inc.
General Hospital · 87d
Cleared Oct 31, 1996
MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT
K963393
Depuy, Inc.
General Hospital · 64d
Cleared Oct 31, 1996
MORRISON MEDICAL WRIST RESTRAINT
K963419
Morrison Medical Products
General Hospital · 62d
Cleared Oct 31, 1996
UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS
K963527
Alimed, Inc.
General Hospital · 57d
Cleared Oct 29, 1996
MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDER
K963378
Medline Industries, Inc.
General Hospital · 63d
Cleared Oct 29, 1996
MEDLINE OPEN END FINGER CONTROL MITT
K963504
Medline
General Hospital · 56d
Cleared Oct 29, 1996
ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES)
K963528
Alimed, Inc.
General Hospital · 55d
Cleared Oct 28, 1996
STRAP WEDGE
K963526
Alimed, Inc.
General Hospital · 54d
Cleared Oct 24, 1996
CHECKMATE ANKLE RESTRAINT SYSTEM
K962963
Hollister, Inc.
General Hospital · 86d
Cleared Oct 24, 1996
HEELBO JOHNNY GRAIT BELT SECURITY BELT
K962964
Hollister, Inc.
General Hospital · 86d
Cleared Oct 18, 1996
THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE
K962831
Heelbo, Inc.
General Hospital · 88d
Cleared Oct 18, 1996
HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING AND STRAP
K962832
Heelbo, Inc.
General Hospital · 88d
Cleared Oct 18, 1996
HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP
K962834
Heelbo, Inc.
General Hospital · 88d
Cleared Oct 18, 1996
HEELBO QUILTED LIMB HOLDER WITH BUCKLE AND STRAP
K962839
Heelbo, Inc.
General Hospital · 88d
Cleared Oct 18, 1996
MEDLINE BODY HOLDER
K963360
Medline Industries, Inc.
General Hospital · 53d
Cleared Oct 18, 1996
MEDLINE SAETY VEST,MEDLINE ECONOMY VEST, MEDLINE TIE-BACK VEST, MEDLINE SECURTIY VEST, VEST RESTRAINT
K963362
Medline Industries, Inc.
General Hospital · 53d
Cleared Oct 18, 1996
MEDLINE PELVIC HOLDER
K963404
Medline Industries, Inc.
General Hospital · 50d
Cleared Oct 18, 1996
MEDLINE ZIPPER SLEEVED VEST
K963452
Medline
General Hospital · 45d