Roto Rest; Trauma and Intensive Care Bed
FDA 510(k) K905113 · Ethos Medical Products , Ltd.
510(k) numberK905113
Submission
- Device name
- Roto Rest; Trauma and Intensive Care Bed
- Applicant
- Ethos Medical Products , Ltd.
Athlone, IE - Received
- November 13, 1990
- Decision date
- November 26, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K905390 | Kudo (Powered Rotation Bed)IKZ · Traditional | Kinetic Concepts, Inc. | 01/08/1991SE |
Questions and answers
When was Roto Rest; Trauma and Intensive Care Bed cleared by the FDA?
Roto Rest; Trauma and Intensive Care Bed (K905113) received a 510(k) decision of Substantially Equivalent on November 26, 1990, 13 days after the submission was received.
What is the product code of K905113?
The FDA product code is IKZ – Bed, Patient Rotation, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5225.