Oscillair 3000 Low Air Loss Kinetic Therapy Bed
FDA 510(k) K923710 · Progressive Medical Technology, Inc.
510(k) numberK923710
Submission
- Device name
- Oscillair 3000 Low Air Loss Kinetic Therapy Bed
- Applicant
- Progressive Medical Technology, Inc.
Lansing, MI, US - Received
- July 27, 1992
- Decision date
- March 22, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code IKZ
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|---|---|---|---|
| K972486 | Pressureguard IVIKZ · Traditional | Span-America Medical Systems, Inc. | 02/20/1998SE |
| K972111 | Rumors Dynamic Air Therapy UnitIKZ · Traditional | Hill-Rom, Inc. | 02/02/1998SE |
| K962788 | Clinidyne Rotational Therapy Mattress SystemIKZ · Traditional | Gaymar Industries, Inc. | 04/30/1997SE |
| K954671 | The Freedom BedIKZ · Traditional | Probed Medical Technologies, Inc. | 04/01/1996SE |
| K950756 | Pulmonex Dynamic Air Therapy UnitIKZ · Traditional | Hill-Rom, Inc. | 05/30/1995SE |
| K950681 | Model Turn Q Plus Automatic Turning Mattress with Low Air Loss TherapyIKZ · Traditional | Invacare Corp. | 05/16/1995SE |
| K933964 | The CradleIKZ · Traditional | The Primal Energy Research Foundation | 10/03/1994SE |
| 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 |
| K905113 | Roto Rest; Trauma and Intensive Care BedIKZ · Traditional | Ethos Medical Products , Ltd. | 11/26/1990SE |
More from Ethos Medical Products , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K915638 | Talley TM200 Intermttent Compression UnitIRP · Traditional | 02/11/1992SE |
| K915637 | Talley TM500 Sequential Multicom Compression Syst.IRP · Traditional | 02/11/1992SE |
| K915092 | Talley TM300 Sequential Multicom Compression SystIRP · Traditional | 02/11/1992SE |
| K915671 | B.A.S.E. Bellows Air Support EquipmentIOQ · Traditional | 01/13/1992SE |
Questions and answers
When was Oscillair 3000 Low Air Loss Kinetic Therapy Bed cleared by the FDA?
Oscillair 3000 Low Air Loss Kinetic Therapy Bed (K923710) received a 510(k) decision of Substantially Equivalent on March 22, 1993, 238 days after the submission was received.
What is the product code of K923710?
The FDA product code is IKZ – Bed, Patient Rotation, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5225.