Model Turn Q Plus Automatic Turning Mattress With Low Air Loss Therapy
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K950681 FDA 510(k)
- FDA Product Code
- IKZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5225 FDA 510(k)
- Regulation Number
- 890.5225 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Model Turn Q Plus is an automatic turning mattress system that provides low air loss therapy. It is designed for pressure ulcer prevention and treatment, turning immobile patients at set intervals. This deep flotation system can directly replace specialty hospital beds and is portable, attaching to most hospital and nursing home beds.
The device replaces the mattress on standard medical beds and offers adjustable turning modes, comfort settings, and safety mechanisms. It is a Class II medical device with FDA 510(k) clearance K950681 under product code IKZ. The device is intended for use in physical medicine settings for patient rotation therapy.
Frequently asked questions
What is the Model Turn Q Plus Automatic Turning Mattress used for?
The Model Turn Q Plus is designed for pressure ulcer prevention and treatment by automatically turning immobile patients at set intervals. It provides low air loss therapy and can directly replace specialty hospital beds in physical medicine settings.
How is the Model Turn Q Plus supplied and installed?
The device replaces the mattress on standard medical beds and is portable, attaching to most hospital and nursing home beds. It offers adjustable turning modes, comfort settings, and safety mechanisms for patient care.
What is the regulatory status of the Model Turn Q Plus?
The Model Turn Q Plus is a Class II medical device with FDA 510(k) clearance K950681 under product code IKZ. It was cleared as substantially equivalent for use in physical medicine settings for patient rotation therapy.
Can the Model Turn Q Plus be used with different bed types?
Yes, the Model Turn Q Plus is designed to be portable and can attach to most hospital and nursing home beds. It functions as a deep flotation system that directly replaces specialty hospital mattresses.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Invacare Turn-Q Plus Mattress User Manual, Invacare microAir Turn-Q Plus Mattress - evika.io, Model Turn Q Plus Automatic Turning Mattress With Low Air Loss Therapy ..., Turn Q Mattress (Lateral Rotation) - Integra Healthcare Equipment
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K950681 | Class II | Active |
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Manufacturer
- Manufacturer
- Invacare Corp.
Sources (1)
- FDA 510(k) K950681 24 fields · synced Sep 27, 2026