FDA Product Code
FDA Product Code FMQ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6760
510(k) Clearances — 134 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K110377 | PROTECTIVE RESTRAINT | Medi-Tech Intl. Corp. | 2011-04-25 | Traditional | PDF ↗ |
| K081264 | STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 | Children'S Health First, Inc. | 2009-02-13 | Traditional | PDF ↗ |
| K080448 | CENTURION PROTECTIVE RESTRAINT, SCR SERIES | Tri-State Hospital Supply Corp. | 2008-08-28 | Traditional | PDF ↗ |
| K013239 | COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES | Med Gen, Inc. | 2001-11-20 | Traditional | PDF ↗ |
| K010818 | INFANT LIMB HOLDER, MODELS 306080 & 306081 | Skil-Care Corp. | 2001-05-24 | Traditional | PDF ↗ |
| K010644 | CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 | Skil-Care Corp. | 2001-05-18 | Traditional | PDF ↗ |
| K991591 | BIOTHANE PATIENT RESTRAINT | Bioplastics | 1999-07-29 | Traditional | PDF ↗ |
| K982178 | VAGABOND SOFT RESTRAINT SYSTEM | Emergent Innovations, Ltd. | 1999-01-26 | Traditional | PDF ↗ |
| K980640 | HEELBO WAIST AND CHEST VEST | Heelbo, Inc. | 1998-05-01 | Traditional | PDF ↗ |
| K972446 | PEDO CUSH PEDO CUDDLE | Cavity Free Kids, Inc. | 1997-11-13 | Traditional | PDF ↗ |
| K972046 | FULL BODY RESTRAINT SYSTEM | Gillen Industries | 1997-08-15 | Traditional | PDF ↗ |
| K971948 | PATIENT RESTRAINT | E.M. Adams Co., Inc. | 1997-08-06 | Traditional | PDF ↗ |
| K972123 | PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 | Smith | 1997-07-25 | Traditional | PDF ↗ |
| K971742 | DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT | Depuy, Inc. | 1997-07-24 | Traditional | PDF ↗ |
| K972338 | PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT. | Geriatric Products, Inc. | 1997-07-24 | Traditional | PDF ↗ |
| K971561 | PROVEST-PROTECTIVE RESTRAINT | Jemm Medical Products | 1997-07-14 | Traditional | PDF ↗ |
| K971536 | RESTRAINTS (VESTS AND JACKETS) | E.M. Adams Co., Inc. | 1997-07-01 | Traditional | PDF ↗ |
| K970273 | PATIENT RESTRAINTS | Fla Orthopedics, Inc. | 1997-04-11 | Traditional | PDF ↗ |
| K970272 | PATIENT RESTRAINT | Fla Orthopedics, Inc. | 1997-04-11 | Traditional | PDF ↗ |
| K970275 | PATIENT RESTRAINTS | Fla Orthopedics, Inc. | 1997-04-11 | Traditional | PDF ↗ |
| K970274 | PATIENT RESTRAINTS | Fla Orthopedics, Inc. | 1997-04-11 | Traditional | PDF ↗ |
| K962327 | SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE | Sekure Seat Corp. | 1997-03-06 | Traditional | PDF ↗ |
| K963466 | PEDIATRIC LIMB HOLDER | Deroyal Industries, Inc. | 1997-02-13 | Traditional | PDF ↗ |
| K963468 | RESTRICTIVE LIMB HOLDER | Deroyal Industries, Inc. | 1997-01-22 | Traditional | PDF ↗ |
| K963474 | TUXEDO VEST RESTRAINT | Deroyal Industries, Inc. | 1997-01-22 | Traditional | PDF ↗ |
| K963476 | DISPOSABLE LIMB HOLDER | Deroyal Industries, Inc. | 1997-01-22 | Traditional | PDF ↗ |
| K963467 | ROLL BELTS | Deroyal Industries, Inc. | 1997-01-03 | Traditional | PDF ↗ |
| K963465 | PELVIC HOLDER | Deroyal Industries, Inc. | 1996-12-19 | Traditional | PDF ↗ |
| K963906 | PATIENT RESTRAINTS | Safety Intl., Inc. | 1996-12-02 | Traditional | PDF ↗ |
| K963547 | THE WRAP IMMOBILIZATION SYSTEM | Safe Restraints, Inc. | 1996-12-02 | Traditional | PDF ↗ |
| K963421 | PROTECTIVE RESTRAINT (WAIST HOLDER) | Kenad SG Medical, Inc. | 1996-11-22 | Traditional | PDF ↗ |
| K963552 | QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350) | Tecnol Medical Products, Inc. | 1996-11-22 | Traditional | PDF ↗ |
| K963559 | WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010) | Tecnol Medical Products, Inc. | 1996-11-22 | Traditional | PDF ↗ |
| K963485 | SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RESRAINT,NYON LIMB HOLDER,VINYL LIMB HOLDER,NYLON BED RESTRAINS | Humane Restraint, Inc. | 1996-11-22 | Traditional | PDF ↗ |
| K963410 | POSEY STRAIGHT JACKETS | J. T. Posey Co. | 1996-11-22 | Traditional | PDF ↗ |
| K963436 | RESTRAINT ACCESSORIES | J. T. Posey Co. | 1996-11-22 | Traditional | PDF ↗ |
| K963430 | PROTECTIVE RESTRAINT (VEST RESTRAINT) | Kenad SG Medical, Inc. | 1996-11-22 | Traditional | PDF ↗ |
| K963414 | MULTIPLE BELTS | J. T. Posey Co. | 1996-11-22 | Traditional | PDF ↗ |
| K963442 | JACKETS AND VESTS | J. T. Posey Co. | 1996-11-22 | Traditional | PDF ↗ |
| K963564 | PERSONAL LIMB HOLDER (24444-200,300,24444-KIT) | Tecnol Medical Products, Inc. | 1996-11-22 | Traditional | PDF ↗ |
| K963422 | PROTECTIVE RESTRAINT (PROTECTIVE MITT) | Kenad SG Medical, Inc. | 1996-11-22 | Traditional | PDF ↗ |
| K963554 | 24448-010 SECURE-ALL FINGER CONTROL MITT | Tecnol Medical Products, Inc. | 1996-11-21 | Traditional | PDF ↗ |
| K963563 | ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145) | Tecnol Medical Products, Inc. | 1996-11-21 | Traditional | PDF ↗ |
| K963556 | SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030) | Tecnol Medical Products, Inc. | 1996-11-21 | Traditional | PDF ↗ |
| K963462 | COMFOR FOAM LIMB HOLDERS- SINGLE STRAP | Bird & Cronin, Inc. | 1996-11-21 | Traditional | PDF ↗ |
| K963557 | SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030 | Tecnol Medical Products, Inc. | 1996-11-21 | Traditional | PDF ↗ |
| K963773 | 24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT | Tecnol Medical Products, Inc. | 1996-11-21 | Traditional | PDF ↗ |
| K963561 | ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040) | Tecnol Medical Products, Inc. | 1996-11-21 | Traditional | PDF ↗ |
| K963411 | POSEY LAPTOP TRAYS | J. T. Posey Co. | 1996-11-19 | Traditional | PDF ↗ |
| K963437 | PELVIC HOLDERS | J. T. Posey Co. | 1996-11-19 | Traditional | PDF ↗ |
| K963439 | PEDIATRIC LIMB HOLDERS | J. T. Posey Co. | 1996-11-19 | Traditional | PDF ↗ |
| K963453 | CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) | Contour Fabricators, Inc. | 1996-11-15 | Traditional | PDF ↗ |
| K963472 | PEDIATRIC VEST RESTRAINT | Deroyal Industries, Inc. | 1996-11-14 | Traditional | PDF ↗ |
| K963478 | SLEEVED/SLEEVELESS VEST RESTRAINT | Deroyal Industries, Inc. | 1996-11-14 | Traditional | PDF ↗ |
| K963473 | REUSABLE LIMB HOLDER | Deroyal Industries, Inc. | 1996-11-14 | Traditional | PDF ↗ |
| K963491 | STUCKEY STRAP-3 FINGER RESTRAINTS | Stuckey Ent., Inc. | 1996-11-14 | Traditional | PDF ↗ |
| K963413 | MULTIPLE LIMB HOLDERS | J. T. Posey Co. | 1996-11-14 | Traditional | PDF ↗ |
| K963470 | CRISS-CROSS VEST RESTRAINT | Deroyal Industries, Inc. | 1996-11-14 | Traditional | PDF ↗ |
| K963409 | POSEY HUGGER | J. T. Posey Co. | 1996-11-14 | Traditional | PDF ↗ |
| K963469 | MITTENS | Deroyal Industries, Inc. | 1996-11-14 | Traditional | PDF ↗ |
| K963471 | SUPER SECURITY RESTRAINT | Deroyal Industries, Inc. | 1996-11-14 | Traditional | PDF ↗ |
| K963464 | RESTRAINT NET | Deroyal Industries, Inc. | 1996-11-12 | Traditional | PDF ↗ |
| K963489 | WHEEL CHAIR ACCESSORY | Smith and Nephew Donjoy, Inc. | 1996-11-12 | Traditional | PDF ↗ |
| K963490 | PROTECTIVE RESTRAINT - BELTS | Smith and Nephew Donjoy, Inc. | 1996-11-12 | Traditional | PDF ↗ |
| K963492 | PROTECTIVE RESTRAINT | Smith and Nephew Donjoy, Inc. | 1996-11-12 | Traditional | PDF ↗ |
| K963477 | PEDIATRIC MITTENS | Deroyal Industries, Inc. | 1996-11-12 | Traditional | PDF ↗ |
| K963374 | TORSO/WAIST RESTRAINT | Morrison Medical Products | 1996-11-08 | Traditional | PDF ↗ |
| K963370 | CINCH STRAP WITH BUCKLE | Morrison Medical Products | 1996-11-08 | Traditional | PDF ↗ |
| K963387 | DELUXE LIMB RESTRAINT WITH DOUBLE D-RING AND STRAP DELUXE LIMB RESTRAINT WITH STRAP | Morrison Medical Products | 1996-11-08 | Traditional | PDF ↗ |
| K963372 | HEELBO ER WRIST RESTRAINT | Heelbo, Inc. | 1996-11-07 | Traditional | PDF ↗ |
| K963371 | BEST STRAP RESTRAINT | Morrison Medical Products | 1996-11-07 | Traditional | PDF ↗ |
| K963435 | ECONOMY SAFETY VEST RESTRAINT, SHOULDER TIE SAFETY VEST/SAFETY VEST RESTRAINT, HEAVY DUTY VEST RESTRAINT, MESH SAFETY VE | Zimmer Patient Care Division | 1996-11-06 | Traditional | PDF ↗ |
| K963431 | POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER | Zimmer, Inc. | 1996-11-06 | Traditional | PDF ↗ |
| K963138 | SPIDER STRAP | Bdm Medical, Inc. | 1996-11-06 | Traditional | PDF ↗ |
| K963399 | MORRISON MEDICAL STRETCHER/COT AND BACKBOARD RESTRAINTS | Morrison Medical Products | 1996-11-06 | Traditional | PDF ↗ |
| K963494 | MORRISON MEDICAL DISPOSABLE RESTRAINT STRAP | Morrison Medical Products | 1996-11-06 | Traditional | PDF ↗ |
| K963416 | ANKLE RESTRAINT SYSTEM | Morrison Medical Products | 1996-11-06 | Traditional | PDF ↗ |
| K963060 | HEELBO SECURITY BELT | Heelbo, Inc. | 1996-11-04 | Traditional | PDF ↗ |
| K963199 | HEELBO PELVIC RESTRAINT | Hollister, Inc. | 1996-11-01 | Traditional | PDF ↗ |
| K963099 | HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET | Heelbo, Inc. | 1996-11-01 | Traditional | PDF ↗ |
| K963527 | UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS | Alimed, Inc. | 1996-10-31 | Traditional | PDF ↗ |
| K963419 | MORRISON MEDICAL WRIST RESTRAINT | Morrison Medical Products | 1996-10-31 | Traditional | PDF ↗ |
| K963041 | HEELBO LIFE JACKET WITH CROTCH SUPPORT | Heelbo, Inc. | 1996-10-31 | Traditional | PDF ↗ |
| K963393 | MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT | Depuy, Inc. | 1996-10-31 | Traditional | PDF ↗ |
| K963528 | ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES) | Alimed, Inc. | 1996-10-29 | Traditional | PDF ↗ |
| K963504 | MEDLINE OPEN END FINGER CONTROL MITT | Medline | 1996-10-29 | Traditional | PDF ↗ |
| K963378 | MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDER | Medline Industries, Inc. | 1996-10-29 | Traditional | PDF ↗ |
| K963526 | STRAP WEDGE | Alimed, Inc. | 1996-10-28 | Traditional | PDF ↗ |
| K962963 | CHECKMATE ANKLE RESTRAINT SYSTEM | Hollister, Inc. | 1996-10-24 | Traditional | PDF ↗ |
| K962964 | HEELBO JOHNNY GRAIT BELT SECURITY BELT | Hollister, Inc. | 1996-10-24 | Traditional | PDF ↗ |
| K963362 | MEDLINE SAETY VEST,MEDLINE ECONOMY VEST, MEDLINE TIE-BACK VEST, MEDLINE SECURTIY VEST, VEST RESTRAINT | Medline Industries, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K963360 | MEDLINE BODY HOLDER | Medline Industries, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K963569 | WHEELCHAIR WAIST BELT, MEDLINE ECONOMY WHEELCHAIR BELT, MEDLINE TWO-PIECE SAFETY SOFT BELT, MEDLINE WHEELCHAIR BELT WITH | Medline Industries, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K963404 | MEDLINE PELVIC HOLDER | Medline Industries, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K962839 | HEELBO QUILTED LIMB HOLDER WITH BUCKLE AND STRAP | Heelbo, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K962831 | THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE | Heelbo, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K963452 | MEDLINE ZIPPER SLEEVED VEST | Medline | 1996-10-18 | Traditional | PDF ↗ |
| K962832 | HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING AND STRAP | Heelbo, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K963458 | PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS | Skil-Care Corp. | 1996-10-18 | Traditional | PDF ↗ |
| K962834 | HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP | Heelbo, Inc. | 1996-10-18 | Traditional | PDF ↗ |
Product code FMQ · Class I · General Hospital. Data: openFDA.