FMQ · Restraint, Protective
General Hospital · 21 CFR 880.6760 · Class 1
Overview
| Product Code | FMQ |
|---|---|
| Device Name | Restraint, Protective |
| Regulation | 21 CFR 880.6760 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
Recent Cleared Devices (20 of 134)
Showing 20 most recent of 134 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K110377 | PROTECTIVE RESTRAINT | Medi-Tech Intl. Corp. | Apr 25, 2011 | SESE |
| K081264 | STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 | Children'S Health First, Inc. | Feb 13, 2009 | SESE |
| K080448 | CENTURION PROTECTIVE RESTRAINT, SCR SERIES | Tri-State Hospital Supply Corp. | Aug 28, 2008 | SESE |
| K013239 | COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES | Med Gen, Inc. | Nov 20, 2001 | SESE |
| K010818 | INFANT LIMB HOLDER, MODELS 306080 & 306081 | Skil-Care Corp. | May 24, 2001 | SESE |
| K010644 | CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 | Skil-Care Corp. | May 18, 2001 | SESE |
| K991591 | BIOTHANE PATIENT RESTRAINT | Bioplastics | Jul 29, 1999 | SESE |
| K982178 | VAGABOND SOFT RESTRAINT SYSTEM | Emergent Innovations, Ltd. | Jan 26, 1999 | SESE |
| K980640 | HEELBO WAIST AND CHEST VEST | Heelbo, Inc. | May 1, 1998 | SESE |
| K972446 | PEDO CUSH PEDO CUDDLE | Cavity Free Kids, Inc. | Nov 13, 1997 | SESE |
| K972046 | FULL BODY RESTRAINT SYSTEM | Gillen Industries | Aug 15, 1997 | SESE |
| K971948 | PATIENT RESTRAINT | E.M. Adams Co., Inc. | Aug 6, 1997 | SESE |
| K972123 | PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 | Smith | Jul 25, 1997 | SESE |
| K972338 | PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT. | Geriatric Products, Inc. | Jul 24, 1997 | SESE |
| K971742 | DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT | Depuy, Inc. | Jul 24, 1997 | SESE |
| K971561 | PROVEST-PROTECTIVE RESTRAINT | Jemm Medical Products | Jul 14, 1997 | SESE |
| K971536 | RESTRAINTS (VESTS AND JACKETS) | E.M. Adams Co., Inc. | Jul 1, 1997 | SESE |
| K970275 | PATIENT RESTRAINTS | Fla Orthopedics, Inc. | Apr 11, 1997 | SESE |
| K970274 | PATIENT RESTRAINTS | Fla Orthopedics, Inc. | Apr 11, 1997 | SESE |
| K970273 | PATIENT RESTRAINTS | Fla Orthopedics, Inc. | Apr 11, 1997 | SESE |
Top Applicants
- Deroyal Industries, Inc. — 15 clearances
- Heelbo, Inc. — 14 clearances
- Skil-Care Corp. — 12 clearances
- J. T. Posey Co. — 9 clearances
- Tecnol Medical Products, Inc. — 9 clearances
