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

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

134 devices
1–24 of 134
Cleared Apr 25, 2011
PROTECTIVE RESTRAINT
K110377
Medi-Tech Intl. Corp.
General Hospital · 75d
Cleared Aug 28, 2008
CENTURION PROTECTIVE RESTRAINT, SCR SERIES
K080448
Tri-State Hospital Supply Corp.
General Hospital · 191d
Cleared May 24, 2001
INFANT LIMB HOLDER, MODELS 306080 & 306081
K010818
Skil-Care Corp.
General Hospital · 66d
Cleared May 18, 2001
CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
K010644
Skil-Care Corp.
General Hospital · 74d
Cleared Jul 29, 1999
BIOTHANE PATIENT RESTRAINT
K991591
Bioplastics
General Hospital · 83d
Cleared Jan 26, 1999
VAGABOND SOFT RESTRAINT SYSTEM
K982178
Emergent Innovations, Ltd.
General Hospital · 218d
Cleared May 01, 1998
HEELBO WAIST AND CHEST VEST
K980640
Heelbo, Inc.
General Hospital · 71d
Cleared Nov 13, 1997
PEDO CUSH PEDO CUDDLE
K972446
Cavity Free Kids, Inc.
General Hospital · 136d
Cleared Aug 15, 1997
FULL BODY RESTRAINT SYSTEM
K972046
Gillen Industries
General Hospital · 74d
Cleared Aug 06, 1997
PATIENT RESTRAINT
K971948
E.M. Adams Co., Inc.
General Hospital · 70d
Cleared Jul 25, 1997
PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905
K972123
Smith
General Hospital · 50d
Cleared Jul 24, 1997
DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT
K971742
Depuy, Inc.
General Hospital · 73d
Cleared Jul 24, 1997
PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT.
K972338
Geriatric Products, Inc.
General Hospital · 31d
Cleared Jul 14, 1997
PROVEST-PROTECTIVE RESTRAINT
K971561
Jemm Medical Products
General Hospital · 76d
Cleared Jul 01, 1997
RESTRAINTS (VESTS AND JACKETS)
K971536
E.M. Adams Co., Inc.
General Hospital · 64d
Cleared Apr 11, 1997
PATIENT RESTRAINT
K970272
Fla Orthopedics, Inc.
General Hospital · 78d
Cleared Apr 11, 1997
PATIENT RESTRAINTS
K970273
Fla Orthopedics, Inc.
General Hospital · 78d
Cleared Apr 11, 1997
PATIENT RESTRAINTS
K970274
Fla Orthopedics, Inc.
General Hospital · 78d
Cleared Apr 11, 1997
PATIENT RESTRAINTS
K970275
Fla Orthopedics, Inc.
General Hospital · 78d
Cleared Mar 06, 1997
SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE
K962327
Sekure Seat Corp.
General Hospital · 262d
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

About Product Code FMQ - Regulatory Context