CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES > SUBPART G—General Hospital and Personal Use Miscellaneous Devices (§880.6025 to §880.6992) > 880.6760—Protective restraint.

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).

Code of Federal Regulations

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