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The indicated use of these Limb Holders, Mitts and Elbow Splints are to be used as a medical restraint to help prevent patient from pulling and disconnecting other medical devices that are being used in their treatment.

These Limb Holders, Mitts and Elbow Splints are intended to be used on hospital beds, wheel chairs, and geriatric chairs. These devices should not be used on extremely violent patients.

LIMB HOLDERS, MITTS & ELBOW SPLINTS

This document is a 510(k) clearance letter from the FDA for a "Patient Restraint" device (K971948). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval notice, not a study report.

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The indicated use of these Vests and Jackets is to be used as a mild restraint. To help prevent the patient from falling, sliding or getting out of bed. The Vests and Jackets can be used in a hospital bed, wheelchair or geriatric chair. These Vests and Jackets should not be used on violent patients.

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The provided text is a 510(k) clearance letter and an "Indications For Use" statement for a medical device: Restraints (Vests and Jackets). This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, or comparative effectiveness studies.

The letter is a regulatory approval, stating that the device is "substantially equivalent" to legally marketed predicate devices, which allows the manufacturer to market the product. It primarily focuses on regulatory compliance rather than clinical performance data from studies.

Therefore, I cannot fulfill your request for the specific details outlined, as they are not present in the provided text.

Ask a specific question about this device