Product Code: FMQ FDA class 1 21 CFR 880.6760

Restraint, Protective

General Hospital

The Protective Restraint is a device used in clinical settings to restrict patient movement, typically to prevent self-harm or interference with medical treatment, in patients who cannot cooperate with care. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FMQ, regulated under 21 CFR 880.6760 in the General Hospital specialty.

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510(k)s

134

FEI Numbers

109

Registration Numbers

109

Unique Applicants

Years Active

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Basic Information

Product Code: FMQ
Device Class: FDA class 1
Regulation Number: 880.6760
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 134 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K110377	PROTECTIVE RESTRAINT	Apr 25, 2011	Substantially Equivalent	Medi-Tech Intl. Corp.
K081264	STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002	Feb 13, 2009	Substantially Equivalent	Children'S Health First, Inc.
K080448	CENTURION PROTECTIVE RESTRAINT, SCR SERIES	Aug 28, 2008	Substantially Equivalent	Tri-State Hospital Supply Corp.
K013239	COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES	Nov 20, 2001	Substantially Equivalent	Med Gen, Inc.
K010818	INFANT LIMB HOLDER, MODELS 306080 & 306081	May 24, 2001	Substantially Equivalent	Skil-Care Corp.
K010644	CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025	May 18, 2001	Substantially Equivalent	Skil-Care Corp.
K991591	BIOTHANE PATIENT RESTRAINT	Jul 29, 1999	Substantially Equivalent	Bioplastics
K982178	VAGABOND SOFT RESTRAINT SYSTEM	Jan 26, 1999	Substantially Equivalent	Emergent Innovations, Ltd.
K980640	HEELBO WAIST AND CHEST VEST	May 01, 1998	Substantially Equivalent	Heelbo, Inc.
K972446	PEDO CUSH PEDO CUDDLE	Nov 13, 1997	Substantially Equivalent	Cavity Free Kids, Inc.
K972046	FULL BODY RESTRAINT SYSTEM	Aug 15, 1997	Substantially Equivalent	Gillen Industries
K971948	PATIENT RESTRAINT	Aug 06, 1997	Substantially Equivalent	E.M. Adams Co., Inc.
K972123	PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905	Jul 25, 1997	Substantially Equivalent	Smith
K972338	PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT.	Jul 24, 1997	Substantially Equivalent	Geriatric Products, Inc.
K971742	DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT	Jul 24, 1997	Substantially Equivalent	Depuy, Inc.
K971561	PROVEST-PROTECTIVE RESTRAINT	Jul 14, 1997	Substantially Equivalent	Jemm Medical Products
K971536	RESTRAINTS (VESTS AND JACKETS)	Jul 01, 1997	Substantially Equivalent	E.M. Adams Co., Inc.
K970275	PATIENT RESTRAINTS	Apr 11, 1997	Substantially Equivalent	Fla Orthopedics, Inc.
K970274	PATIENT RESTRAINTS	Apr 11, 1997	Substantially Equivalent	Fla Orthopedics, Inc.
K970273	PATIENT RESTRAINTS	Apr 11, 1997	Substantially Equivalent	Fla Orthopedics, Inc.
K970272	PATIENT RESTRAINT	Apr 11, 1997	Substantially Equivalent	Fla Orthopedics, Inc.
K962327	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	Mar 06, 1997	Substantially Equivalent	Sekure Seat Corp.
K963466	PEDIATRIC LIMB HOLDER	Feb 13, 1997	Substantially Equivalent	Deroyal Industries, Inc.
K963476	DISPOSABLE LIMB HOLDER	Jan 22, 1997	Substantially Equivalent	Deroyal Industries, Inc.
K963474	TUXEDO VEST RESTRAINT	Jan 22, 1997	Substantially Equivalent	Deroyal Industries, Inc.
K963468	RESTRICTIVE LIMB HOLDER	Jan 22, 1997	Substantially Equivalent	Deroyal Industries, Inc.
K963467	ROLL BELTS	Jan 03, 1997	Substantially Equivalent	Deroyal Industries, Inc.
K963465	PELVIC HOLDER	Dec 19, 1996	Substantially Equivalent	Deroyal Industries, Inc.
K963906	PATIENT RESTRAINTS	Dec 02, 1996	Substantially Equivalent	Safety Intl., Inc.
K963547	THE WRAP IMMOBILIZATION SYSTEM	Dec 02, 1996	Substantially Equivalent	Safe Restraints, Inc.
K963564	PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)	Nov 22, 1996	Substantially Equivalent	Tecnol Medical Products, Inc.
K963559	WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)	Nov 22, 1996	Substantially Equivalent	Tecnol Medical Products, Inc.
K963552	QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)	Nov 22, 1996	Substantially Equivalent	Tecnol Medical Products, Inc.
K963485	SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RESRAINT,NYON LIMB HOLDER,VINYL LIMB HOLDER,NYLON BED RESTRAINS	Nov 22, 1996	Substantially Equivalent	Humane Restraint, Inc.
K963442	JACKETS AND VESTS	Nov 22, 1996	Substantially Equivalent	J. T. Posey Co.
K963436	RESTRAINT ACCESSORIES	Nov 22, 1996	Substantially Equivalent	J. T. Posey Co.
K963430	PROTECTIVE RESTRAINT (VEST RESTRAINT)	Nov 22, 1996	Substantially Equivalent	Kenad SG Medical, Inc.
K963422	PROTECTIVE RESTRAINT (PROTECTIVE MITT)	Nov 22, 1996	Substantially Equivalent	Kenad SG Medical, Inc.
K963421	PROTECTIVE RESTRAINT (WAIST HOLDER)	Nov 22, 1996	Substantially Equivalent	Kenad SG Medical, Inc.
K963414	MULTIPLE BELTS	Nov 22, 1996	Substantially Equivalent	J. T. Posey Co.
K963410	POSEY STRAIGHT JACKETS	Nov 22, 1996	Substantially Equivalent	J. T. Posey Co.
K963773	24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT	Nov 21, 1996	Substantially Equivalent	Tecnol Medical Products, Inc.
K963563	ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145)	Nov 21, 1996	Substantially Equivalent	Tecnol Medical Products, Inc.
K963561	ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040)	Nov 21, 1996	Substantially Equivalent	Tecnol Medical Products, Inc.
K963557	SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030	Nov 21, 1996	Substantially Equivalent	Tecnol Medical Products, Inc.
K963556	SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030)	Nov 21, 1996	Substantially Equivalent	Tecnol Medical Products, Inc.
K963554	24448-010 SECURE-ALL FINGER CONTROL MITT	Nov 21, 1996	Substantially Equivalent	Tecnol Medical Products, Inc.
K963462	COMFOR FOAM LIMB HOLDERS- SINGLE STRAP	Nov 21, 1996	Substantially Equivalent	Bird & Cronin, Inc.
K963439	PEDIATRIC LIMB HOLDERS	Nov 19, 1996	Substantially Equivalent	J. T. Posey Co.
K963437	PELVIC HOLDERS	Nov 19, 1996	Substantially Equivalent	J. T. Posey Co.
K963411	POSEY LAPTOP TRAYS	Nov 19, 1996	Substantially Equivalent	J. T. Posey Co.
K963453	CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046)	Nov 15, 1996	Substantially Equivalent	Contour Fabricators, Inc.
K963491	STUCKEY STRAP-3 FINGER RESTRAINTS	Nov 14, 1996	Substantially Equivalent	Stuckey Ent., Inc.
K963478	SLEEVED/SLEEVELESS VEST RESTRAINT	Nov 14, 1996	Substantially Equivalent	Deroyal Industries, Inc.
K963473	REUSABLE LIMB HOLDER	Nov 14, 1996	Substantially Equivalent	Deroyal Industries, Inc.
K963472	PEDIATRIC VEST RESTRAINT	Nov 14, 1996	Substantially Equivalent	Deroyal Industries, Inc.
K963471	SUPER SECURITY RESTRAINT	Nov 14, 1996	Substantially Equivalent	Deroyal Industries, Inc.
K963470	CRISS-CROSS VEST RESTRAINT	Nov 14, 1996	Substantially Equivalent	Deroyal Industries, Inc.
K963469	MITTENS	Nov 14, 1996	Substantially Equivalent	Deroyal Industries, Inc.
K963413	MULTIPLE LIMB HOLDERS	Nov 14, 1996	Substantially Equivalent	J. T. Posey Co.
K963409	POSEY HUGGER	Nov 14, 1996	Substantially Equivalent	J. T. Posey Co.
K963492	PROTECTIVE RESTRAINT	Nov 12, 1996	Substantially Equivalent	Smith and Nephew Donjoy, Inc.
K963490	PROTECTIVE RESTRAINT - BELTS	Nov 12, 1996	Substantially Equivalent	Smith and Nephew Donjoy, Inc.
K963489	WHEEL CHAIR ACCESSORY	Nov 12, 1996	Substantially Equivalent	Smith and Nephew Donjoy, Inc.
K963477	PEDIATRIC MITTENS	Nov 12, 1996	Substantially Equivalent	Deroyal Industries, Inc.
K963464	RESTRAINT NET	Nov 12, 1996	Substantially Equivalent	Deroyal Industries, Inc.
K963387	DELUXE LIMB RESTRAINT WITH DOUBLE D-RING AND STRAP DELUXE LIMB RESTRAINT WITH STRAP	Nov 08, 1996	Substantially Equivalent	Morrison Medical Products
K963374	TORSO/WAIST RESTRAINT	Nov 08, 1996	Substantially Equivalent	Morrison Medical Products
K963370	CINCH STRAP WITH BUCKLE	Nov 08, 1996	Substantially Equivalent	Morrison Medical Products
K963372	HEELBO ER WRIST RESTRAINT	Nov 07, 1996	Substantially Equivalent	Heelbo, Inc.
K963371	BEST STRAP RESTRAINT	Nov 07, 1996	Substantially Equivalent	Morrison Medical Products
K963494	MORRISON MEDICAL DISPOSABLE RESTRAINT STRAP	Nov 06, 1996	Substantially Equivalent	Morrison Medical Products
K963435	ECONOMY SAFETY VEST RESTRAINT, SHOULDER TIE SAFETY VEST/SAFETY VEST RESTRAINT, HEAVY DUTY VEST RESTRAINT, MESH SAFETY VE	Nov 06, 1996	Substantially Equivalent	Zimmer Patient Care Division
K963431	POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER	Nov 06, 1996	Substantially Equivalent	Zimmer, Inc.
K963416	ANKLE RESTRAINT SYSTEM	Nov 06, 1996	Substantially Equivalent	Morrison Medical Products
K963399	MORRISON MEDICAL STRETCHER/COT AND BACKBOARD RESTRAINTS	Nov 06, 1996	Substantially Equivalent	Morrison Medical Products
K963138	SPIDER STRAP	Nov 06, 1996	Substantially Equivalent	Bdm Medical, Inc.
K963060	HEELBO SECURITY BELT	Nov 04, 1996	Substantially Equivalent	Heelbo, Inc.
K963199	HEELBO PELVIC RESTRAINT	Nov 01, 1996	Substantially Equivalent	Hollister, Inc.
K963099	HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET	Nov 01, 1996	Substantially Equivalent	Heelbo, Inc.
K963527	UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS	Oct 31, 1996	Substantially Equivalent	Alimed, Inc.
K963419	MORRISON MEDICAL WRIST RESTRAINT	Oct 31, 1996	Substantially Equivalent	Morrison Medical Products
K963393	MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT	Oct 31, 1996	Substantially Equivalent	Depuy, Inc.
K963041	HEELBO LIFE JACKET WITH CROTCH SUPPORT	Oct 31, 1996	Substantially Equivalent	Heelbo, Inc.
K963528	ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES)	Oct 29, 1996	Substantially Equivalent	Alimed, Inc.
K963504	MEDLINE OPEN END FINGER CONTROL MITT	Oct 29, 1996	Substantially Equivalent	Medline
K963378	MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDER	Oct 29, 1996	Substantially Equivalent	Medline Industries, Inc.
K963526	STRAP WEDGE	Oct 28, 1996	Substantially Equivalent	Alimed, Inc.
K962964	HEELBO JOHNNY GRAIT BELT SECURITY BELT	Oct 24, 1996	Substantially Equivalent	Hollister, Inc.
K962963	CHECKMATE ANKLE RESTRAINT SYSTEM	Oct 24, 1996	Substantially Equivalent	Hollister, Inc.
K963569	WHEELCHAIR WAIST BELT, MEDLINE ECONOMY WHEELCHAIR BELT, MEDLINE TWO-PIECE SAFETY SOFT BELT, MEDLINE WHEELCHAIR BELT WITH	Oct 18, 1996	Substantially Equivalent	Medline Industries, Inc.
K963458	PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS	Oct 18, 1996	Substantially Equivalent	Skil-Care Corp.
K963452	MEDLINE ZIPPER SLEEVED VEST	Oct 18, 1996	Substantially Equivalent	Medline
K963404	MEDLINE PELVIC HOLDER	Oct 18, 1996	Substantially Equivalent	Medline Industries, Inc.
K963362	MEDLINE SAETY VEST,MEDLINE ECONOMY VEST, MEDLINE TIE-BACK VEST, MEDLINE SECURTIY VEST, VEST RESTRAINT	Oct 18, 1996	Substantially Equivalent	Medline Industries, Inc.
K963360	MEDLINE BODY HOLDER	Oct 18, 1996	Substantially Equivalent	Medline Industries, Inc.
K962839	HEELBO QUILTED LIMB HOLDER WITH BUCKLE AND STRAP	Oct 18, 1996	Substantially Equivalent	Heelbo, Inc.
K962834	HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP	Oct 18, 1996	Substantially Equivalent	Heelbo, Inc.
K962832	HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING AND STRAP	Oct 18, 1996	Substantially Equivalent	Heelbo, Inc.
K962831	THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE	Oct 18, 1996	Substantially Equivalent	Heelbo, Inc.
K963463	STRAIT JACKET	Oct 16, 1996	Substantially Equivalent	Deroyal Industries, Inc.
K963294	HEELBO WRAP AROUND VEST	Oct 11, 1996	Substantially Equivalent	Heelbo, Inc.
K963460	ROLL BELT	Oct 09, 1996	Substantially Equivalent	Skil-Care Corp.
K963457	SLEEPER JACKET/HOUDINI SAFETY SLEEPER	Oct 09, 1996	Substantially Equivalent	Skil-Care Corp.
K963237	HEELBO ICU 911 BLAZER SLEEVED JACKET	Oct 09, 1996	Substantially Equivalent	Heelbo, Inc.
K963108	HEELBO QUILTED TORSO RESTRAINT	Oct 09, 1996	Substantially Equivalent	Hollister, Inc.
K962810	GREAT HANDS MITTS	Oct 09, 1996	Substantially Equivalent	Heelbo, Inc.
K962778	THE L-BOW ARM RESTRAINT	Oct 09, 1996	Substantially Equivalent	Heelbo, Inc.
K963456	LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER	Oct 08, 1996	Substantially Equivalent	Skil-Care Corp.
K963454	CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE CUSHION BELT	Oct 07, 1996	Substantially Equivalent	Skil-Care Corp.
K963450	SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VEST	Oct 07, 1996	Substantially Equivalent	Skil-Care Corp.
K963449	PELVIC HOLDER	Oct 07, 1996	Substantially Equivalent	Skil-Care Corp.
K963448	ECONO BELT	Oct 07, 1996	Substantially Equivalent	Skil-Care Corp.
K963447	DOUBLE SUPPORT PONCHO/SLIDER PONCHO	Oct 07, 1996	Substantially Equivalent	Skil-Care Corp.
K962626	PATIENT PROTECTIVE LIMB	Oct 02, 1996	Substantially Equivalent	Kenad SG Medical, Inc.
K963243	HEELBO BLAZER SLEEVED JACKET	Oct 01, 1996	Substantially Equivalent	Heelbo, Inc.
K962429	SAFETY VEST	Sep 18, 1996	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K925924	NEAL WRIST CONES	Apr 08, 1993	Substantially Equivalent	Neal & Assoc., Inc.
K850470	BED PRODUCTS	Apr 01, 1985	Substantially Equivalent	Abco Dealers, Inc.
K812473	HEAD PROTECTOR	Dec 02, 1981	Substantially Equivalent	Maddak, Inc.
K801272	TECNOL QUICK RELEASE LIMB HOLDER	Jun 17, 1980	Substantially Equivalent	Tecnol New Jersey Wound Care, Inc.
K792012	SKIL-CARE SUPER-SOFT LIMB RESTRAINTS	Oct 26, 1979	Substantially Equivalent	Skil-Care Corp.
K790699	TECNOL BODY HOLDER	Jun 01, 1979	Substantially Equivalent	Tecnol New Jersey Wound Care, Inc.
K790172	BK-5098 TILT TABLE STRAP	Feb 27, 1979	Substantially Equivalent	Fred Sammons, Inc.
K780232	RESTRAINT, PROTECTIVE	Feb 21, 1978	Substantially Equivalent	Biomet, Inc.
K771659	PATIENT RESTRAINT SYSTEM	Sep 30, 1977	Substantially Equivalent	Mtd, Inc.
K771636	BODY RESTRAINT	Sep 30, 1977	Substantially Equivalent	Medical Restraints, Inc.
K771630	LIMB RESTRAINT	Sep 30, 1977	Substantially Equivalent	Medical Restraints, Inc.
K771629	HAND RESTRAINT	Sep 30, 1977	Substantially Equivalent	Medical Restraints, Inc.
K771715	PELVIC WHEELCHAIR RESTRAINT	Sep 28, 1977	Substantially Equivalent	Medical Restraints, Inc.
K771635	FOOT ELEVATOR	Sep 28, 1977	Substantially Equivalent	Medical Restraints, Inc.
K771634	VEST RESTRAINT	Sep 28, 1977	Substantially Equivalent	Medical Restraints, Inc.
K771632	FINGER MITT RESTRAINT	Sep 28, 1977	Substantially Equivalent	Medical Restraints, Inc.
K760618	PATIENT RESTRAINT	Nov 24, 1976	Substantially Equivalent	Encompass Group, LLC