(76 days)
These products are intended to limit limb movement or finger movement in a hospital bed or gurney.
The devices included in this 510(k) submission limit limb movement and/or finger movement. The product is closed around the patient by encircling the wrists, hands, or ankles. The product is secured to the bed or gurney via straps. These straps are securely connected to the bed, genatic chair, or wheelchair by one or more of the following: knots, corset buckles, keyed lock buckles, square rings, hook and loop, standard buckles, or quick release buckles.
This document describes a 510(k) submission for protective restraints (limb holders) by T. T. Posey Co. It does not describe an AI/ML device or any study that would involve acceptance criteria, performance metrics, ground truth, or expert review in the context of AI/ML.
Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a medical device (protective restraints) that has been on the market for a long time, not a submission for a new AI/ML-driven diagnostic or therapeutic device.
§ 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.