(70 days)
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.
§ 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.