# K972486: Pressureguard IV

- Pathway: 510(k) (Traditional)
- Applicant: Span-America Medical Systems, Inc.
- Decided: Feb 20, 1998 after 233 days
- Product code: IKZ (Bed, Patient Rotation, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953503 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953503: Pressureguard IV, Span-America Medical Systems, Inc. (1995) Summary page 1.

## Indications for use
For the prevention and treatment of pressure ulcers. Patient lateral rotation of up to 30 degrees may also be used as a preventive tool against further complications associated with critically ill patients or immobility.

Source page: https://510kreport.com/device/K972486
Methodology: https://510kreport.com/methodology