MORRISON MEDICAL DISPOSABLE RESTRAINT STRAP

• K Number: K963494
• Device Name: MORRISON MEDICAL DISPOSABLE RESTRAINT STRAP
• Manufacturer: MORRISON MEDICAL PRODUCTS
• Date Cleared: 1996-11-06 ( 64 days)
• Product Code: FMQ
• Regulation Number: 880.6760
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Morrison Medical Disposable Restraint Strap is intended to help secure a patient's body while lying on a backboard.

Device Description

The Morrison Medical Disposable Restraint Strap is intended to help secure a patient's body while lying on a backboard. The straps are constructed of an acrylic coated polyester woven material with an adhesive band on each end of the strap. The patient is secured to the backboard by lying the strap across the patient's body and peeling the release paper from the strap. The strap is woven through the hand hold in the backboard and stuck back onto the polyester strap. After use the strap is cut off with scissors.

AI/ML Overview

This document is a 510(k) premarket notification for a disposable restraint strap, not a study evaluating a device's performance against acceptance criteria using statistical methods. Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, or expert involvement.

The document states that the "subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification." The only difference is revised product labeling.

This implies that the device's safety and effectiveness are established by its substantial equivalence to a predicate device, not through a new study with specific performance acceptance criteria.

Regulation Number and Section

§ 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.