(122 days)
The DeRoyal Industries, Inc. Roll Belt is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby enabling examination or protection of the patient or others. The DeRoyal Industries, Inc. Roll Belt is intended to be used with a bed.
The DeRoyal Industries, Inc. Roll Belt is a protective restraint device that is intended for medical purposes to limit patient movements so that the patient remains in the bed while allowing the patient to move from side to side thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Roll Belt is designed similar to those marketed by other manufacturers. The Roll Belt is primarily comprised of nylon or polyester seat belt webbing and cotton flannel.
The provided text is a 510(k) summary for the DeRoyal Industries, Inc. Roll Belt, a protective restraint device. It describes the device, its intended use, and compares its characteristics to other similar devices.
*However, this document does not contain any information regarding acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or any details related to AI/ML performance or MRMC studies.
Therefore, I cannot provide the requested information. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than a detailed performance study with defined acceptance criteria.
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K963467
JAN. 3, 1997
DeRoyal Industries, Inc. Roll Belt
510(k) Summary
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
DeRoyal Industries, Inc. NAME: 200 DeBusk Lane ADDRESS: Powell, TN 37849
TELEPHONE: CONTACT: DATE OF PREPARATION: (423) 938-7828 Camille Matlock August 30, 1996
DEVICE NAMES
DeRoyal Industries, Inc. Roll Belt NAME: Roll Belt COMMON/USUAL NAME: CLASSIFICATION NAME (if known): Restraint, Protective (80FMQ)
PREDICATE OR LEGALLY MARKETED DEVICES
J.T. Posev Company DeRoyal Industries, Inc.
DEVICE DESCRIPTION
The DeRoyal Industries, Inc. Roll Belt is a protective restraint device that is intended for medical purposes to limit patient movements so that the patient remains in the bed while allowing the patient to move from side to side thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Roll Belt is designed similar to those marketed by other manufacturers. The Roll Belt is primarily comprised of nylon or polyester seat belt webbing and cotton flannel.
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Roll Belt is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby enabling examination or protection of the patient or others. The DeRoyal Industries, Inc. Roll Belt is intended to be used with a bed.
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Materials | Primarily comprised of nylon or polyester seatbelt webbing. Materials also include cottonflannel and foam rubber for soft padding.Fasteners are either a hook and loop or abuckle. | Same |
| Size | Small, Medium, and Large | Same |
| Vehicles forAttachment | Bed | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of PatientActivity | Mildly Agitated or disoriented | Same |
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
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§ 880.6760 Protective restraint.
(a)
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.(b)
Classification. 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.