Product code FMQ
- Device name
- Restraint, Protective
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.6760
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110377 | PROTECTIVE RESTRAINT | Medi-Tech Intl. Corp. | 2011-04-25 |
| K081264 | STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 | Children'S Health First, Inc. | 2009-02-13 |
| K080448 | CENTURION PROTECTIVE RESTRAINT, SCR SERIES | Tri-State Hospital Supply Corp. | 2008-08-28 |
| K013239 | COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES | Med Gen, Inc. | 2001-11-20 |
| K010818 | INFANT LIMB HOLDER, MODELS 306080 & 306081 | Skil-Care Corp. | 2001-05-24 |
| K010644 | CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 | Skil-Care Corp. | 2001-05-18 |
| K991591 | BIOTHANE PATIENT RESTRAINT | Bioplastics | 1999-07-29 |
| K982178 | VAGABOND SOFT RESTRAINT SYSTEM | Emergent Innovations, Ltd. | 1999-01-26 |
| K980640 | HEELBO WAIST AND CHEST VEST | Heelbo, Inc. | 1998-05-01 |
| K972446 | PEDO CUSH PEDO CUDDLE | Cavity Free Kids, Inc. | 1997-11-13 |
| K972046 | FULL BODY RESTRAINT SYSTEM | Gillen Industries | 1997-08-15 |
| K971948 | PATIENT RESTRAINT | E.M. Adams Co., Inc. | 1997-08-06 |
| K972123 | PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 | Smith | 1997-07-25 |
| K971742 | DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT | Depuy, Inc. | 1997-07-24 |
| K972338 | PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT. | Geriatric Products, Inc. | 1997-07-24 |
| K971561 | PROVEST-PROTECTIVE RESTRAINT | Jemm Medical Products | 1997-07-14 |
| K971536 | RESTRAINTS (VESTS AND JACKETS) | E.M. Adams Co., Inc. | 1997-07-01 |
| K970275 | PATIENT RESTRAINTS | Fla Orthopedics, Inc. | 1997-04-11 |
| K970274 | PATIENT RESTRAINTS | Fla Orthopedics, Inc. | 1997-04-11 |
| K970273 | PATIENT RESTRAINTS | Fla Orthopedics, Inc. | 1997-04-11 |
| K970272 | PATIENT RESTRAINT | Fla Orthopedics, Inc. | 1997-04-11 |
| K962327 | SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE | Sekure Seat Corp. | 1997-03-06 |
| K963466 | PEDIATRIC LIMB HOLDER | Deroyal Industries, Inc. | 1997-02-13 |
| K963468 | RESTRICTIVE LIMB HOLDER | Deroyal Industries, Inc. | 1997-01-22 |
| K963474 | TUXEDO VEST RESTRAINT | Deroyal Industries, Inc. | 1997-01-22 |
| K963476 | DISPOSABLE LIMB HOLDER | Deroyal Industries, Inc. | 1997-01-22 |
| K963467 | ROLL BELTS | Deroyal Industries, Inc. | 1997-01-03 |
| K963465 | PELVIC HOLDER | Deroyal Industries, Inc. | 1996-12-19 |
| K963906 | PATIENT RESTRAINTS | Safety Intl., Inc. | 1996-12-02 |
| K963547 | THE WRAP IMMOBILIZATION SYSTEM | Safe Restraints, Inc. | 1996-12-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08436035354092 | Salvacel | MEDI CARE SYSTEM SLU | 2019-11-26 |
| 08436035353125 | Salvaclip Safe | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035354825 | Salvast | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035354801 | Salvast | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035354191 | Bodyfix | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035354078 | Salvacel | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035354054 | Salvacel | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035353484 | Bodyfix | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035353194 | Salvaclip Safe | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035353187 | Salvaclip Safe | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035353170 | Salvaclip Safe | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035353163 | Salvaclip Safe | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035353156 | Salvaclip Safe | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035353149 | Salvaclip Safe | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035353132 | Salvaclip Safe | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035350063 | Salvacel | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035353118 | Salvaclip Safe | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035353101 | Salvaclip Safe | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035352326 | Salvacel | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035350469 | Salvacel | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035350445 | Salvacel | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035350421 | Salvacel | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035350407 | Salvacel | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035350384 | Salvacel | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035350360 | Salvacel | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035350346 | Salvacel | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035350322 | Salvacel | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035350308 | Salvacel | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035350285 | Salvacel | MEDI CARE SYSTEM SLU | 2019-11-22 |
| 08436035350261 | Salvacel | MEDI CARE SYSTEM SLU | 2019-11-22 |