Definition: Enclosed Bed Canopy System Used As Passive Restraint.
| Device Type ID | 2734 |
| Device Name | Patient Bed With Canopy/restraints |
| Physical State | It May Consist Of The Following Components: (a) Metal/aluminum Rectangular Frame (b) Polyurethane Or Like Material For Tubular Foam Padding For The Aluminum Frame (c) Four Side Panels Composed Of Polyurethane-coated Nylon Pack Cloth, Gray Polyester M |
| Technical Method | It Is A Passive Bed Enclosure That Provides A Solid Framework And A Soft Canopy Structure, Which Securely Attaches To The Bed And Shelters And Restrains The Patient Without Touching The Patient. The Canopy Provides Access To The Patient Through Secur |
| Target Area | Entire Body |
| Regulation Description | Protective Restraint. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.6760 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OYS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2734 |
| Device | Patient Bed With Canopy/restraints |
| Product Code | OYS |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Protective Restraint. |
| CFR Regulation Number | 880.6760 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Component | 11 |
Mechanical Problem | 5 |
Break | 4 |
Use Of Device Problem | 4 |
Component Missing | 3 |
Material Separation | 3 |
Defective Component | 2 |
Structural Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Labelling, Instructions For Use Or Training Problem | 1 |
Torn Material | 1 |
Device Damaged Prior To Use | 1 |
| Total Device Problems | 37 |