Egerton Turning & Tilting Bed
510(k) K834563
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK834563 | Date30 Jan 1984 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IKZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5225
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Egerton Turning & Tilting Bed is a Powered, Patient Rotation Bed designed for physical medicine applications. It facilitates patient repositioning and mobility through controlled turning and tilting mechanisms, aiding in pressure relief, comfort, and therapeutic positioning for individuals with limited mobility or prolonged bed rest.
This device is supplied as a reusable medical bed system, intended for use in clinical settings such as hospitals, rehabilitation centers, and long-term care facilities. It is classified as a Class II device under FDA regulations (890.5225) and holds a FDA 510(k) clearance (K834563) for substantial equivalence in physical medicine applications. The bed operates with electric power and requires proper maintenance and storage per manufacturer guidelines.
Other devices from Kinetic Concepts, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Egerton Turning & Tilting Bed used for?
The Egerton Turning & Tilting Bed is designed for physical medicine applications to assist with patient repositioning and mobility. Its controlled turning and tilting mechanisms help alleviate pressure points, enhance comfort, and support therapeutic positioning—ideal for individuals with limited mobility or those requiring prolonged bed rest in hospitals, rehabilitation centers, or long-term care facilities.
Is the Egerton Turning & Tilting Bed reusable or single-use?
This device is supplied as a reusable medical bed system. It is intended for repeated use in clinical environments, provided it undergoes proper maintenance and cleaning as outlined by the manufacturer’s guidelines to ensure safety and functionality.
What types of clinical settings is this bed intended for?
The Egerton Turning & Tilting Bed is specifically engineered for use in clinical settings such as hospitals, rehabilitation centers, and long-term care facilities. Its design supports environments where patient mobility assistance, pressure relief, and therapeutic positioning are critical for recovery or ongoing care.
How does the bed’s tilting and turning mechanism benefit patients?
The bed’s controlled tilting and turning mechanisms allow for gradual and precise repositioning of patients, reducing the risk of pressure ulcers and discomfort. This feature is particularly beneficial for individuals with limited mobility, as it promotes better circulation, minimizes skin irritation, and supports a more comfortable therapeutic positioning experience.
What maintenance or storage requirements does the Egerton Turning & Tilting Bed have?
The bed requires adherence to the manufacturer’s maintenance and storage guidelines to ensure optimal performance and longevity. Regular cleaning, inspection for wear or damage, and proper electrical safety checks are essential. Storage should be in a dry, climate-controlled environment to prevent corrosion or mechanical failure, as outlined in Kinetic Concepts’ operational manual.