Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6760](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6760) → OYS — Patient Bed With Canopy/Restraints

# OYS · Patient Bed With Canopy/Restraints

_General Hospital · 21 CFR 880.6760 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/OYS

## Overview

- **Product Code:** OYS
- **Device Name:** Patient Bed With Canopy/Restraints
- **Regulation:** [21 CFR 880.6760](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6760)
- **Device Class:** 1
- **Review Panel:** [General Hospital](/submissions/HO)

## 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](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/OYS/K113355.md) | POSEY BED | J. T. Posey Co. | May 2, 2012 | SESE |
| [K113357](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/OYS/K113357.md) | POSEY BED | J. T. Posey Co. | Mar 21, 2012 | SESE |
| [K103817](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/OYS/K103817.md) | POSEY BED | J. T. Posey Co. | Apr 22, 2011 | SESE |

## Top Applicants

- J. T. Posey Co. — 3 clearances

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/OYS](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/OYS)

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