(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).
[61 FR 8439, Mar. 4, 1996, as amended at 66 FR 46952, Sept. 10, 2001]