FMQ · Class I · 21 CFR 880.6760

FDA Product Code FMQ: Restraint, Protective

Leading manufacturers include Medline Industries, Inc., Depuy, Inc. and Biomet, 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 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 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 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
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 Sep 18, 1996
SAFETY VEST
K962429
Johnson & Johnson Professionals, Inc.
General Hospital · 86d
Cleared Feb 27, 1979
BK-5098 TILT TABLE STRAP
K790172
Fred Sammons, Inc.
General Hospital · 32d
Cleared Feb 21, 1978
RESTRAINT, PROTECTIVE
K780232
Biomet, Inc.
General Hospital · 12d

About Product Code FMQ - Regulatory Context