Model Turn Q Plus Automatic Turning Mattress with Low Air Loss Therapy
FDA 510(k) K950681 · Invacare Corp.
510(k) numberK950681
Submission
- Device name
- Model Turn Q Plus Automatic Turning Mattress with Low Air Loss Therapy
- Applicant
- Invacare Corp.
Elyria, OH, US - Received
- February 14, 1995
- Decision date
- May 16, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IKZ – Bed, Patient Rotation, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5225
- Specialty
- Physical Medicine
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| K933964 | The CradleIKZ · Traditional | The Primal Energy Research Foundation | 10/03/1994SE |
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| K922473 | Turn Ez Bed DeviceIKZ · Traditional | Med-Ez, Inc. | 09/09/1992SE |
| K905390 | Kudo (Powered Rotation Bed)IKZ · Traditional | Kinetic Concepts, Inc. | 01/08/1991SE |
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Questions and answers
When was Model Turn Q Plus Automatic Turning Mattress with Low Air Loss Therapy cleared by the FDA?
Model Turn Q Plus Automatic Turning Mattress with Low Air Loss Therapy (K950681) received a 510(k) decision of Substantially Equivalent on May 16, 1995, 91 days after the submission was received.
What is the product code of K950681?
The FDA product code is IKZ – Bed, Patient Rotation, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5225.