FDA 510(k) Applications for Medical Device Product Code "FMQ"
(Restraint, Protective)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K963528 | ALIMED, INC. | ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES) | 10/29/1996 |
| K963526 | ALIMED, INC. | STRAP WEDGE | 10/28/1996 |
| K963527 | ALIMED, INC. | UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS | 10/31/1996 |
| K963138 | BDM MEDICAL, INC. | SPIDER STRAP | 11/06/1996 |
| K991591 | BIOPLASTICS | BIOTHANE PATIENT RESTRAINT | 07/29/1999 |
| K963462 | BIRD & CRONIN, INC. | COMFOR FOAM LIMB HOLDERS- SINGLE STRAP | 11/21/1996 |
| K972446 | CAVITY FREE KIDS, INC. | PEDO CUSH PEDO CUDDLE | 11/13/1997 |
| K081264 | CHILDREN'S HEALTH FIRST, INC. | STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 | 02/13/2009 |
| K963453 | CONTOUR FABRICATORS, INC. | CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) | 11/15/1996 |
| K971742 | DEPUY, INC. | DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT | 07/24/1997 |
| K963393 | DEPUY, INC. | MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT | 10/31/1996 |
| K963470 | DEROYAL INDUSTRIES, INC. | CRISS-CROSS VEST RESTRAINT | 11/14/1996 |
| K963476 | DEROYAL INDUSTRIES, INC. | DISPOSABLE LIMB HOLDER | 01/22/1997 |
| K963469 | DEROYAL INDUSTRIES, INC. | MITTENS | 11/14/1996 |
| K963466 | DEROYAL INDUSTRIES, INC. | PEDIATRIC LIMB HOLDER | 02/13/1997 |
| K963477 | DEROYAL INDUSTRIES, INC. | PEDIATRIC MITTENS | 11/12/1996 |
| K963472 | DEROYAL INDUSTRIES, INC. | PEDIATRIC VEST RESTRAINT | 11/14/1996 |
| K963465 | DEROYAL INDUSTRIES, INC. | PELVIC HOLDER | 12/19/1996 |
| K963464 | DEROYAL INDUSTRIES, INC. | RESTRAINT NET | 11/12/1996 |
| K963468 | DEROYAL INDUSTRIES, INC. | RESTRICTIVE LIMB HOLDER | 01/22/1997 |
| K963473 | DEROYAL INDUSTRIES, INC. | REUSABLE LIMB HOLDER | 11/14/1996 |
| K963467 | DEROYAL INDUSTRIES, INC. | ROLL BELTS | 01/03/1997 |
| K963478 | DEROYAL INDUSTRIES, INC. | SLEEVED/SLEEVELESS VEST RESTRAINT | 11/14/1996 |
| K963463 | DEROYAL INDUSTRIES, INC. | STRAIT JACKET | 10/16/1996 |
| K963471 | DEROYAL INDUSTRIES, INC. | SUPER SECURITY RESTRAINT | 11/14/1996 |
| K963474 | DEROYAL INDUSTRIES, INC. | TUXEDO VEST RESTRAINT | 01/22/1997 |
| K971948 | E.M. ADAMS CO., INC. | PATIENT RESTRAINT | 08/06/1997 |
| K971536 | E.M. ADAMS CO., INC. | RESTRAINTS (VESTS AND JACKETS) | 07/01/1997 |
| K982178 | EMERGENT INNOVATIONS, LTD. | VAGABOND SOFT RESTRAINT SYSTEM | 01/26/1999 |
| K970272 | FLA. ORTHOPEDICS, INC. | PATIENT RESTRAINT | 04/11/1997 |
| K970273 | FLA. ORTHOPEDICS, INC. | PATIENT RESTRAINTS | 04/11/1997 |
| K970274 | FLA. ORTHOPEDICS, INC. | PATIENT RESTRAINTS | 04/11/1997 |
| K970275 | FLA. ORTHOPEDICS, INC. | PATIENT RESTRAINTS | 04/11/1997 |
| K972338 | GERIATRIC PRODUCTS, INC. | PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT. | 07/24/1997 |
| K972046 | GILLEN INDUSTRIES | FULL BODY RESTRAINT SYSTEM | 08/15/1997 |
| K962810 | HEELBO, INC. | GREAT HANDS MITTS | 10/09/1996 |
| K963243 | HEELBO, INC. | HEELBO BLAZER SLEEVED JACKET | 10/01/1996 |
| K963372 | HEELBO, INC. | HEELBO ER WRIST RESTRAINT | 11/07/1996 |
| K963237 | HEELBO, INC. | HEELBO ICU 911 BLAZER SLEEVED JACKET | 10/09/1996 |
| K963041 | HEELBO, INC. | HEELBO LIFE JACKET WITH CROTCH SUPPORT | 10/31/1996 |
| K963099 | HEELBO, INC. | HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET | 11/01/1996 |
| K962839 | HEELBO, INC. | HEELBO QUILTED LIMB HOLDER WITH BUCKLE AND STRAP | 10/18/1996 |
| K962832 | HEELBO, INC. | HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING AND STRAP | 10/18/1996 |
| K962834 | HEELBO, INC. | HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP | 10/18/1996 |
| K963060 | HEELBO, INC. | HEELBO SECURITY BELT | 11/04/1996 |
| K980640 | HEELBO, INC. | HEELBO WAIST AND CHEST VEST | 05/01/1998 |
| K963294 | HEELBO, INC. | HEELBO WRAP AROUND VEST | 10/11/1996 |
| K962831 | HEELBO, INC. | THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE | 10/18/1996 |
| K962778 | HEELBO, INC. | THE L-BOW ARM RESTRAINT | 10/09/1996 |
| K962963 | HOLLISTER, INC. | CHECKMATE ANKLE RESTRAINT SYSTEM | 10/24/1996 |
| K962964 | HOLLISTER, INC. | HEELBO JOHNNY GRAIT BELT SECURITY BELT | 10/24/1996 |
| K963199 | HOLLISTER, INC. | HEELBO PELVIC RESTRAINT | 11/01/1996 |
| K963108 | HOLLISTER, INC. | HEELBO QUILTED TORSO RESTRAINT | 10/09/1996 |
| K963485 | HUMANE RESTRAINT, INC. | SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RESRAINT,NYON LIMB HOLDER,VINYL LIMB HOLDER,NYLON BED RESTRAINS | 11/22/1996 |
| K963442 | J. T. POSEY CO. | JACKETS AND VESTS | 11/22/1996 |
| K963414 | J. T. POSEY CO. | MULTIPLE BELTS | 11/22/1996 |
| K963413 | J. T. POSEY CO. | MULTIPLE LIMB HOLDERS | 11/14/1996 |
| K963439 | J. T. POSEY CO. | PEDIATRIC LIMB HOLDERS | 11/19/1996 |
| K963437 | J. T. POSEY CO. | PELVIC HOLDERS | 11/19/1996 |
| K963409 | J. T. POSEY CO. | POSEY HUGGER | 11/14/1996 |
| K963411 | J. T. POSEY CO. | POSEY LAPTOP TRAYS | 11/19/1996 |
| K963410 | J. T. POSEY CO. | POSEY STRAIGHT JACKETS | 11/22/1996 |
| K963436 | J. T. POSEY CO. | RESTRAINT ACCESSORIES | 11/22/1996 |
| K971561 | JEMM MEDICAL PRODUCTS | PROVEST-PROTECTIVE RESTRAINT | 07/14/1997 |
| K962429 | JOHNSON & JOHNSON PROFESSIONALS, INC. | SAFETY VEST | 09/18/1996 |
| K962626 | KENAD SG MEDICAL, INC. | PATIENT PROTECTIVE LIMB | 10/02/1996 |
| K963422 | KENAD SG MEDICAL, INC. | PROTECTIVE RESTRAINT (PROTECTIVE MITT) | 11/22/1996 |
| K963430 | KENAD SG MEDICAL, INC. | PROTECTIVE RESTRAINT (VEST RESTRAINT) | 11/22/1996 |
| K963421 | KENAD SG MEDICAL, INC. | PROTECTIVE RESTRAINT (WAIST HOLDER) | 11/22/1996 |
| K013239 | MED GEN, INC. | COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES | 11/20/2001 |
| K110377 | MEDI-TECH INTL. CORP. | PROTECTIVE RESTRAINT | 04/25/2011 |
| K963504 | MEDLINE | MEDLINE OPEN END FINGER CONTROL MITT | 10/29/1996 |
| K963452 | MEDLINE | MEDLINE ZIPPER SLEEVED VEST | 10/18/1996 |
| K963360 | MEDLINE INDUSTRIES, INC. | MEDLINE BODY HOLDER | 10/18/1996 |
| K963378 | MEDLINE INDUSTRIES, INC. | MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDER | 10/29/1996 |
| K963404 | MEDLINE INDUSTRIES, INC. | MEDLINE PELVIC HOLDER | 10/18/1996 |
| K963362 | MEDLINE INDUSTRIES, INC. | MEDLINE SAETY VEST,MEDLINE ECONOMY VEST, MEDLINE TIE-BACK VEST, MEDLINE SECURTIY VEST, VEST RESTRAINT | 10/18/1996 |
| K963569 | MEDLINE INDUSTRIES, INC. | WHEELCHAIR WAIST BELT, MEDLINE ECONOMY WHEELCHAIR BELT, MEDLINE TWO-PIECE SAFETY SOFT BELT, MEDLINE WHEELCHAIR BELT WITH | 10/18/1996 |
| K963416 | MORRISON MEDICAL PRODUCTS | ANKLE RESTRAINT SYSTEM | 11/06/1996 |
| K963371 | MORRISON MEDICAL PRODUCTS | BEST STRAP RESTRAINT | 11/07/1996 |
| K963370 | MORRISON MEDICAL PRODUCTS | CINCH STRAP WITH BUCKLE | 11/08/1996 |
| K963387 | MORRISON MEDICAL PRODUCTS | DELUXE LIMB RESTRAINT WITH DOUBLE D-RING AND STRAP DELUXE LIMB RESTRAINT WITH STRAP | 11/08/1996 |
| K963494 | MORRISON MEDICAL PRODUCTS | MORRISON MEDICAL DISPOSABLE RESTRAINT STRAP | 11/06/1996 |
| K963399 | MORRISON MEDICAL PRODUCTS | MORRISON MEDICAL STRETCHER/COT AND BACKBOARD RESTRAINTS | 11/06/1996 |
| K963419 | MORRISON MEDICAL PRODUCTS | MORRISON MEDICAL WRIST RESTRAINT | 10/31/1996 |
| K963374 | MORRISON MEDICAL PRODUCTS | TORSO/WAIST RESTRAINT | 11/08/1996 |
| K963547 | SAFE RESTRAINTS, INC. | THE WRAP IMMOBILIZATION SYSTEM | 12/02/1996 |
| K963906 | SAFETY INTL., INC. | PATIENT RESTRAINTS | 12/02/1996 |
| K962327 | SEKURE SEAT CORP. | SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE | 03/06/1997 |
| K010644 | SKIL-CARE CORP. | CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 | 05/18/2001 |
| K963454 | SKIL-CARE CORP. | CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE CUSHION BELT | 10/07/1996 |
| K963447 | SKIL-CARE CORP. | DOUBLE SUPPORT PONCHO/SLIDER PONCHO | 10/07/1996 |
| K963448 | SKIL-CARE CORP. | ECONO BELT | 10/07/1996 |
| K010818 | SKIL-CARE CORP. | INFANT LIMB HOLDER, MODELS 306080 & 306081 | 05/24/2001 |
| K963456 | SKIL-CARE CORP. | LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER | 10/08/1996 |
| K963458 | SKIL-CARE CORP. | PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS | 10/18/1996 |
| K963449 | SKIL-CARE CORP. | PELVIC HOLDER | 10/07/1996 |
| K963460 | SKIL-CARE CORP. | ROLL BELT | 10/09/1996 |
| K963450 | SKIL-CARE CORP. | SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VEST | 10/07/1996 |
| K963457 | SKIL-CARE CORP. | SLEEPER JACKET/HOUDINI SAFETY SLEEPER | 10/09/1996 |
| K972123 | SMITH | PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 | 07/25/1997 |
| K963492 | SMITH AND NEPHEW DONJOY, INC. | PROTECTIVE RESTRAINT | 11/12/1996 |
| K963490 | SMITH AND NEPHEW DONJOY, INC. | PROTECTIVE RESTRAINT - BELTS | 11/12/1996 |
| K963489 | SMITH AND NEPHEW DONJOY, INC. | WHEEL CHAIR ACCESSORY | 11/12/1996 |
| K963491 | STUCKEY ENT., INC. | STUCKEY STRAP-3 FINGER RESTRAINTS | 11/14/1996 |
| K963554 | TECNOL MEDICAL PRODUCTS, INC. | 24448-010 SECURE-ALL FINGER CONTROL MITT | 11/21/1996 |
| K963773 | TECNOL MEDICAL PRODUCTS, INC. | 24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT | 11/21/1996 |
| K963564 | TECNOL MEDICAL PRODUCTS, INC. | PERSONAL LIMB HOLDER (24444-200,300,24444-KIT) | 11/22/1996 |
| K963552 | TECNOL MEDICAL PRODUCTS, INC. | QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350) | 11/22/1996 |
| K963556 | TECNOL MEDICAL PRODUCTS, INC. | SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030) | 11/21/1996 |
| K963557 | TECNOL MEDICAL PRODUCTS, INC. | SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030 | 11/21/1996 |
| K963561 | TECNOL MEDICAL PRODUCTS, INC. | ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040) | 11/21/1996 |
| K963563 | TECNOL MEDICAL PRODUCTS, INC. | ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145) | 11/21/1996 |
| K963559 | TECNOL MEDICAL PRODUCTS, INC. | WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010) | 11/22/1996 |
| K080448 | TRI-STATE HOSPITAL SUPPLY CORP. | CENTURION PROTECTIVE RESTRAINT, SCR SERIES | 08/28/2008 |
| K963435 | ZIMMER PATIENT CARE DIVISION | ECONOMY SAFETY VEST RESTRAINT, SHOULDER TIE SAFETY VEST/SAFETY VEST RESTRAINT, HEAVY DUTY VEST RESTRAINT, MESH SAFETY VE | 11/06/1996 |
| K963431 | ZIMMER, INC. | POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER | 11/06/1996 |
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