FMQ · Class I · 21 CFR 880.6760

FDA Product Code FMQ: Restraint, Protective

Leading manufacturers include Deroyal Industries, Inc., Medline Industries, Inc. and Hollister, Inc..

134
Total
134
Cleared
74d
Avg days
1976
Since

FDA 510(k) Cleared Restraint, Protective Devices (Product Code FMQ)

134 devices
1–24 of 134
Cleared Jul 24, 1997
DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT
K971742
Depuy, Inc.
General Hospital · 73d
Cleared Feb 13, 1997
PEDIATRIC LIMB HOLDER
K963466
Deroyal Industries, Inc.
General Hospital · 163d
Cleared Jan 22, 1997
RESTRICTIVE LIMB HOLDER
K963468
Deroyal Industries, Inc.
General Hospital · 141d
Cleared Jan 22, 1997
TUXEDO VEST RESTRAINT
K963474
Deroyal Industries, Inc.
General Hospital · 141d
Cleared Jan 22, 1997
DISPOSABLE LIMB HOLDER
K963476
Deroyal Industries, Inc.
General Hospital · 141d
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 Nov 14, 1996
MITTENS
K963469
Deroyal Industries, Inc.
General Hospital · 72d
Cleared Nov 14, 1996
CRISS-CROSS VEST RESTRAINT
K963470
Deroyal Industries, Inc.
General Hospital · 72d
Cleared Nov 14, 1996
SUPER SECURITY RESTRAINT
K963471
Deroyal Industries, Inc.
General Hospital · 72d
Cleared Nov 14, 1996
PEDIATRIC VEST RESTRAINT
K963472
Deroyal Industries, Inc.
General Hospital · 72d
Cleared Nov 14, 1996
REUSABLE LIMB HOLDER
K963473
Deroyal Industries, Inc.
General Hospital · 72d
Cleared Nov 14, 1996
SLEEVED/SLEEVELESS VEST RESTRAINT
K963478
Deroyal Industries, Inc.
General Hospital · 72d
Cleared Nov 12, 1996
RESTRAINT NET
K963464
Deroyal Industries, Inc.
General Hospital · 70d
Cleared Nov 12, 1996
PEDIATRIC MITTENS
K963477
Deroyal Industries, Inc.
General Hospital · 70d
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 01, 1996
HEELBO PELVIC RESTRAINT
K963199
Hollister, Inc.
General Hospital · 78d
Cleared Oct 31, 1996
MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT
K963393
Depuy, Inc.
General Hospital · 64d
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 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
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

About Product Code FMQ - Regulatory Context