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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 Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(K) Exempt
Regulation Number 880.6760
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible