PATIENT RESTRAINT
Device Facts
| Record ID | K760618 |
|---|---|
| Device Name | PATIENT RESTRAINT |
| Applicant | Encompass Group, LLC |
| Product Code | FMQ · General Hospital |
| Decision Date | Nov 24, 1976 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6760 |
| Device Class | Class 1 |
Regulatory Classification
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.
