(72 days)
The Morrison Medical Best Strap Restraint is a restraint system intended to help to secure a patient's body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard.
The Morrison Medical Best Strap is a restraint system comprised of five nylon straps with Hook and Loop that helps to secure a patient's body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard. The straps are color coded to assist in the application of the device. The straps are threaded around the backboard or stretcher frame and secured with the Hook and Loop to allow for quick and easy application and release.
The provided text does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies for the Morrison Medical Products Best Strap Restraint.
The document is a "Safety and Effectiveness Summary" for a 510(k) submission, primarily focusing on demonstrating substantial equivalence to a predicate device. It describes the device, its intended use, and technological characteristics, and states that there are no changes to the device itself but only to the labeling to comply with regulatory guidance. It also briefly mentions biocompatibility.
Therefore, I cannot fulfill the request to build a table of acceptance criteria and reported device performance or provide details on the studies as the information is not present in the given text.
§ 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.