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
97–120 of 134
Cleared Oct 18, 1996
PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS
K963458
Skil-Care Corp.
General Hospital · 45d
Cleared Oct 18, 1996
WHEELCHAIR WAIST BELT, MEDLINE ECONOMY WHEELCHAIR BELT, MEDLINE TWO-PIECE SAFETY SOFT BELT, MEDLINE WHEELCHAIR BELT WITH
K963569
Medline Industries, Inc.
General Hospital · 43d
Cleared Oct 16, 1996
STRAIT JACKET
K963463
Deroyal Industries, Inc.
General Hospital · 43d
Cleared Oct 11, 1996
HEELBO WRAP AROUND VEST
K963294
Heelbo, Inc.
General Hospital · 51d
Cleared Oct 09, 1996
THE L-BOW ARM RESTRAINT
K962778
Heelbo, Inc.
General Hospital · 84d
Cleared Oct 09, 1996
GREAT HANDS MITTS
K962810
Heelbo, Inc.
General Hospital · 83d
Cleared Oct 09, 1996
HEELBO QUILTED TORSO RESTRAINT
K963108
Hollister, Inc.
General Hospital · 58d
Cleared Oct 09, 1996
HEELBO ICU 911 BLAZER SLEEVED JACKET
K963237
Heelbo, Inc.
General Hospital · 51d
Cleared Oct 09, 1996
SLEEPER JACKET/HOUDINI SAFETY SLEEPER
K963457
Skil-Care Corp.
General Hospital · 36d
Cleared Oct 09, 1996
ROLL BELT
K963460
Skil-Care Corp.
General Hospital · 36d
Cleared Oct 08, 1996
LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER
K963456
Skil-Care Corp.
General Hospital · 35d
Cleared Oct 07, 1996
DOUBLE SUPPORT PONCHO/SLIDER PONCHO
K963447
Skil-Care Corp.
General Hospital · 34d
Cleared Oct 07, 1996
ECONO BELT
K963448
Skil-Care Corp.
General Hospital · 34d
Cleared Oct 07, 1996
PELVIC HOLDER
K963449
Skil-Care Corp.
General Hospital · 34d
Cleared Oct 07, 1996
SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VEST
K963450
Skil-Care Corp.
General Hospital · 34d
Cleared Oct 07, 1996
CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE CUSHION BELT
K963454
Skil-Care Corp.
General Hospital · 34d
Cleared Oct 02, 1996
PATIENT PROTECTIVE LIMB
K962626
Kenad SG Medical, Inc.
General Hospital · 89d
Cleared Oct 01, 1996
HEELBO BLAZER SLEEVED JACKET
K963243
Heelbo, Inc.
General Hospital · 43d
Cleared Sep 18, 1996
SAFETY VEST
K962429
Johnson & Johnson Professionals, Inc.
General Hospital · 86d
Cleared Apr 01, 1985
BED PRODUCTS
K850470
Abco Dealers, Inc.
General Hospital · 63d
Cleared Dec 02, 1981
HEAD PROTECTOR
K812473
Maddak, Inc.
General Hospital · 93d
Cleared Jun 17, 1980
TECNOL QUICK RELEASE LIMB HOLDER
K801272
Tecnol New Jersey Wound Care, Inc.
General Hospital · 20d
Cleared Oct 26, 1979
SKIL-CARE SUPER-SOFT LIMB RESTRAINTS
K792012
Skil-Care Corp.
General Hospital · 21d
Cleared Jun 01, 1979
TECNOL BODY HOLDER
K790699
Tecnol New Jersey Wound Care, Inc.
General Hospital · 50d