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 |
|---|---|---|---|
| Oct 16, 1996 | K963463 | STRAIT JACKET Deroyal Industries, Inc. | FMQ |
| Oct 11, 1996 | K963294 | HEELBO WRAP AROUND VEST Heelbo, Inc. | FMQ |
| Oct 9, 1996 | K963460 | ROLL BELT Skil-Care Corp. | FMQ |
| Oct 9, 1996 | K963457 | SLEEPER JACKET/HOUDINI SAFETY SLEEPER Skil-Care Corp. | FMQ |
| Oct 9, 1996 | K963237 | HEELBO ICU 911 BLAZER SLEEVED JACKET Heelbo, Inc. | FMQ |
| Oct 9, 1996 | K963108 | HEELBO QUILTED TORSO RESTRAINT Hollister, Inc. | FMQ |
| Oct 9, 1996 | K962810 | GREAT HANDS MITTS Heelbo, Inc. | FMQ |
| Oct 9, 1996 | K962778 | THE L-BOW ARM RESTRAINT Heelbo, Inc. | FMQ |
| Oct 8, 1996 | K963456 | LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER Skil-Care Corp. | FMQ |
| Oct 7, 1996 | K963454 | CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE CUSHION BELT Skil-Care Corp. | FMQ |
| Oct 7, 1996 | K963450 | SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VEST Skil-Care Corp. | FMQ |
| Oct 7, 1996 | K963449 | PELVIC HOLDER Skil-Care Corp. | FMQ |
| Oct 7, 1996 | K963448 | ECONO BELT Skil-Care Corp. | FMQ |
| Oct 7, 1996 | K963447 | DOUBLE SUPPORT PONCHO/SLIDER PONCHO Skil-Care Corp. | FMQ |
| Oct 2, 1996 | K962626 | PATIENT PROTECTIVE LIMB Kenad SG Medical, Inc. | FMQ |
| Oct 1, 1996 | K963243 | HEELBO BLAZER SLEEVED JACKET Heelbo, Inc. | FMQ |
| Sep 18, 1996 | K962429 | SAFETY VEST Johnson & Johnson Professionals, Inc. | FMQ |
| Apr 8, 1993 | K925924 | NEAL WRIST CONES Neal & Assoc., Inc. | FMQ |
| Apr 1, 1985 | K850470 | BED PRODUCTS Abco Dealers, Inc. | FMQ |
| Dec 2, 1981 | K812473 | HEAD PROTECTOR Maddak, Inc. | FMQ |
| Jun 17, 1980 | K801272 | TECNOL QUICK RELEASE LIMB HOLDER Tecnol New Jersey Wound Care, Inc. | FMQ |
| Oct 26, 1979 | K792012 | SKIL-CARE SUPER-SOFT LIMB RESTRAINTS Skil-Care Corp. | FMQ |
| Jun 1, 1979 | K790699 | TECNOL BODY HOLDER Tecnol New Jersey Wound Care, Inc. | FMQ |
| Feb 27, 1979 | K790172 | BK-5098 TILT TABLE STRAP Fred Sammons, Inc. | FMQ |
| Feb 21, 1978 | K780232 | RESTRAINT, PROTECTIVE Biomet, Inc. | FMQ |
| Sep 30, 1977 | K771659 | PATIENT RESTRAINT SYSTEM Mtd, Inc. | FMQ |
| Sep 30, 1977 | K771636 | BODY RESTRAINT Medical Restraints, Inc. | FMQ |
| Sep 30, 1977 | K771630 | LIMB RESTRAINT Medical Restraints, Inc. | FMQ |
| Sep 30, 1977 | K771629 | HAND RESTRAINT Medical Restraints, Inc. | FMQ |
| Sep 28, 1977 | K771715 | PELVIC WHEELCHAIR RESTRAINT Medical Restraints, Inc. | FMQ |
| Sep 28, 1977 | K771635 | FOOT ELEVATOR Medical Restraints, Inc. | FMQ |
| Sep 28, 1977 | K771634 | VEST RESTRAINT Medical Restraints, Inc. | FMQ |
| Sep 28, 1977 | K771632 | FINGER MITT RESTRAINT Medical Restraints, Inc. | FMQ |
| Nov 24, 1976 | K760618 | PATIENT RESTRAINT Encompass Group, LLC | FMQ |
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