Clinidyne Rotational Therapy Mattress System
FDA 510(k) K962788 · Gaymar Industries, Inc.
510(k) numberK962788
Submission
- Device name
- Clinidyne Rotational Therapy Mattress System
- Applicant
- Gaymar Industries, Inc.
Orchard Park, NY, US - Received
- July 17, 1996
- Decision date
- April 30, 1997
- 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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| K954671 | The Freedom BedIKZ · Traditional | Probed Medical Technologies, Inc. | 04/01/1996SE |
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| K933964 | The CradleIKZ · Traditional | The Primal Energy Research Foundation | 10/03/1994SE |
| K923710 | Oscillair 3000 Low Air Loss Kinetic Therapy BedIKZ · Traditional | Progressive Medical Technology, Inc. | 03/22/1993SE |
| K922473 | Turn Ez Bed DeviceIKZ · Traditional | Med-Ez, Inc. | 09/09/1992SE |
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| K930345 | TC2000 Power Unit and AccessoriesDWJ · Traditional | 08/06/1993SE |
| K914921 | SCM-3 and AccessoriesIKY · Traditional | 03/12/1992SE |
| K914805 | TC-1000, TC-1050 SystemDWJ · Traditional | 01/07/1992SE |
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Questions and answers
When was Clinidyne Rotational Therapy Mattress System cleared by the FDA?
Clinidyne Rotational Therapy Mattress System (K962788) received a 510(k) decision of Substantially Equivalent on April 30, 1997, 287 days after the submission was received.
What is the product code of K962788?
The FDA product code is IKZ – Bed, Patient Rotation, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5225.