Pressureguard IV
FDA 510(k) K972486 · Span-America Medical Systems, Inc.
510(k) numberK972486
Submission
- Device name
- Pressureguard IV
- Applicant
- Span-America Medical Systems, Inc.
Greenville, SC, US - Received
- July 2, 1997
- Decision date
- February 20, 1998
- 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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|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K973169 | Pressure Guard Site Select (a)FNM · Traditional | 02/20/1998SE |
| K960188 | Pressureguard: SelectcareFNM · Traditional | 10/02/1996SE |
| K961502 | Lubricating Jelly, Low ViscosityKMJ · Traditional | 07/18/1996SE |
| K961159 | Powered Low Air Loss Mattress SystemFNM · Traditional | 06/14/1996SE |
| K960620 | Pressureguard: Low Air Loss Mattress SystemFNM · Traditional | 04/25/1996SE |
| K960189 | Gel-T CushionKIC · Traditional | 02/07/1996SE |
| K954766 | Pressure Guard Alternating Pressure MattressFNM · Traditional | 01/11/1996SE |
| K953503 | Pressureguard IVFNM · Traditional | 10/24/1995SE |
| K954117 | Customcare Seating SystemKIC · Traditional | 10/13/1995SE |
| K951112 | Pressureguard IVFNM · Traditional | 06/06/1995SE |
Questions and answers
When was Pressureguard IV cleared by the FDA?
Pressureguard IV (K972486) received a 510(k) decision of Substantially Equivalent on February 20, 1998, 233 days after the submission was received.
What is the product code of K972486?
The FDA product code is IKZ – Bed, Patient Rotation, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5225.