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U.S. Department of Health and Human Services

Product Classification

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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 CodeOYS
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)
Regulation Number 880.6760
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible