| Device |
patient bed with canopy/restraints |
| Regulation Description |
Protective restraint. |
| Definition |
Enclosed bed canopy system used as passive restraint. |
| 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 mesh (or similar materials) and polyester coiled zippers with an enclosed canopy. |
| 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 secured openings, allowing the healthcare worker the ability to provide routine care to the patient, while providing a more controlled environment when the patient is unattended. |
| Target Area |
entire body |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | OYS |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.6760
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
