Panels › General Hospital › Product code FMQ · Class 1
Restraint, Protective
Regulation 880.6760
0510(k)s in 12 months (134 all time)
0recalls in 12 months (33 all time)
25recalls that name a 510(k)
Top companies in FMQ
| Company | 510(k)s | Recalls |
|---|---|---|
| J. T. Posey Co. | 9 | 25 |
| Deroyal Industries, Inc. | 15 | 3 |
| Heelbo, Inc. | 14 | 0 |
| Skil-Care Corp. | 12 | 0 |
| Tecnol Medical Products, Inc. | 9 | 0 |
| Morrison Medical Products | 8 | 0 |
| Medical Restraints, Inc. | 7 | 0 |
| Medline Industries, Inc. | 5 | 0 |
| Fla Orthopedics, Inc. | 4 | 0 |
| Hollister, Inc. | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 25, 2011 | K110377 | PROTECTIVE RESTRAINT Medi-Tech Intl. Corp. | FMQ |
| Feb 13, 2009 | K081264 | STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 Children'S Health First, Inc. | FMQ |
| Aug 28, 2008 | K080448 | CENTURION PROTECTIVE RESTRAINT, SCR SERIES Tri-State Hospital Supply Corp. | FMQ |
| Nov 20, 2001 | K013239 | COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES Med Gen, Inc. | FMQ |
| May 24, 2001 | K010818 | INFANT LIMB HOLDER, MODELS 306080 & 306081 Skil-Care Corp. | FMQ |
| May 18, 2001 | K010644 | CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 Skil-Care Corp. | FMQ |
| Jul 29, 1999 | K991591 | BIOTHANE PATIENT RESTRAINT Bioplastics | FMQ |
| Jan 26, 1999 | K982178 | VAGABOND SOFT RESTRAINT SYSTEM Emergent Innovations, Ltd. | FMQ |
| May 1, 1998 | K980640 | HEELBO WAIST AND CHEST VEST Heelbo, Inc. | FMQ |
| Nov 13, 1997 | K972446 | PEDO CUSH PEDO CUDDLE Cavity Free Kids, Inc. | FMQ |
| Aug 15, 1997 | K972046 | FULL BODY RESTRAINT SYSTEM Gillen Industries | FMQ |
| Aug 6, 1997 | K971948 | PATIENT RESTRAINT E.M. Adams Co., Inc. | FMQ |
| Jul 25, 1997 | K972123 | PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 Smith | FMQ |
| Jul 24, 1997 | K972338 | PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT. Geriatric Products, Inc. | FMQ |
| Jul 24, 1997 | K971742 | DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT Depuy, Inc. | FMQ |
| Jul 14, 1997 | K971561 | PROVEST-PROTECTIVE RESTRAINT Jemm Medical Products | FMQ |
| Jul 1, 1997 | K971536 | RESTRAINTS (VESTS AND JACKETS) E.M. Adams Co., Inc. | FMQ |
| Apr 11, 1997 | K970275 | PATIENT RESTRAINTS Fla Orthopedics, Inc. | FMQ |
| Apr 11, 1997 | K970274 | PATIENT RESTRAINTS Fla Orthopedics, Inc. | FMQ |
| Apr 11, 1997 | K970273 | PATIENT RESTRAINTS Fla Orthopedics, Inc. | FMQ |
| Apr 11, 1997 | K970272 | PATIENT RESTRAINT Fla Orthopedics, Inc. | FMQ |
| Mar 6, 1997 | K962327 | SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE Sekure Seat Corp. | FMQ |
| Feb 13, 1997 | K963466 | PEDIATRIC LIMB HOLDER Deroyal Industries, Inc. | FMQ |
| Jan 22, 1997 | K963476 | DISPOSABLE LIMB HOLDER Deroyal Industries, Inc. | FMQ |
| Jan 22, 1997 | K963474 | TUXEDO VEST RESTRAINT Deroyal Industries, Inc. | FMQ |
| Jan 22, 1997 | K963468 | RESTRICTIVE LIMB HOLDER Deroyal Industries, Inc. | FMQ |
| Jan 3, 1997 | K963467 | ROLL BELTS Deroyal Industries, Inc. | FMQ |
| Dec 19, 1996 | K963465 | PELVIC HOLDER Deroyal Industries, Inc. | FMQ |
| Dec 2, 1996 | K963906 | PATIENT RESTRAINTS Safety Intl., Inc. | FMQ |
| Dec 2, 1996 | K963547 | THE WRAP IMMOBILIZATION SYSTEM Safe Restraints, Inc. | FMQ |
| Nov 22, 1996 | K963564 | PERSONAL LIMB HOLDER (24444-200,300,24444-KIT) Tecnol Medical Products, Inc. | FMQ |
| Nov 22, 1996 | K963559 | WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010) Tecnol Medical Products, Inc. | FMQ |
| Nov 22, 1996 | K963552 | QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350) Tecnol Medical Products, Inc. | FMQ |
| Nov 22, 1996 | K963485 | SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RESRAINT,NYON LIMB HOLDER,VINYL LIMB HOLDER,NYLON BED RESTRAINS Humane Restraint, Inc. | FMQ |
| Nov 22, 1996 | K963442 | JACKETS AND VESTS J. T. Posey Co. | FMQ |
| Nov 22, 1996 | K963436 | RESTRAINT ACCESSORIES J. T. Posey Co. | FMQ |
| Nov 22, 1996 | K963430 | PROTECTIVE RESTRAINT (VEST RESTRAINT) Kenad SG Medical, Inc. | FMQ |
| Nov 22, 1996 | K963422 | PROTECTIVE RESTRAINT (PROTECTIVE MITT) Kenad SG Medical, Inc. | FMQ |
| Nov 22, 1996 | K963421 | PROTECTIVE RESTRAINT (WAIST HOLDER) Kenad SG Medical, Inc. | FMQ |
| Nov 22, 1996 | K963414 | MULTIPLE BELTS J. T. Posey Co. | FMQ |
| Nov 22, 1996 | K963410 | POSEY STRAIGHT JACKETS J. T. Posey Co. | FMQ |
| Nov 21, 1996 | K963773 | 24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT Tecnol Medical Products, Inc. | FMQ |
| Nov 21, 1996 | 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. | FMQ |
| Nov 21, 1996 | K963561 | ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040) Tecnol Medical Products, Inc. | FMQ |
| Nov 21, 1996 | K963557 | SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030 Tecnol Medical Products, Inc. | FMQ |
| Nov 21, 1996 | K963556 | SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030) Tecnol Medical Products, Inc. | FMQ |
| Nov 21, 1996 | K963554 | 24448-010 SECURE-ALL FINGER CONTROL MITT Tecnol Medical Products, Inc. | FMQ |
| Nov 21, 1996 | K963462 | COMFOR FOAM LIMB HOLDERS- SINGLE STRAP Bird & Cronin, Inc. | FMQ |
| Nov 19, 1996 | K963439 | PEDIATRIC LIMB HOLDERS J. T. Posey Co. | FMQ |
| Nov 19, 1996 | K963437 | PELVIC HOLDERS J. T. Posey Co. | FMQ |
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