OYS · Patient Bed With Canopy/Restraints
General Hospital · 21 CFR 880.6760 · Class 1
Overview
| Product Code | OYS |
|---|---|
| Device Name | Patient Bed With Canopy/Restraints |
| Regulation | 21 CFR 880.6760 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
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.
Classification Rationale
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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K113355 | POSEY BED | J. T. Posey Co. | May 2, 2012 | SESE |
| K113357 | POSEY BED | J. T. Posey Co. | Mar 21, 2012 | SESE |
| K103817 | POSEY BED | J. T. Posey Co. | Apr 22, 2011 | SESE |
Top Applicants
- J. T. Posey Co. — 3 clearances
