# K961159: Powered Low Air Loss Mattress System

- Pathway: 510(k) (Traditional)
- Applicant: Span-America Medical Systems, Inc.
- Decided: Jun 14, 1996 after 84 days
- Product code: FNM (Mattress, Air Flotation, Alternating Pressure)
- Device class: 2
- Regulation: 21 CFR 880.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K951112 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960620: Pressureguard: Low Air Loss Mattress System, Span-America Medical Systems, Inc. (1996). Cleared while this submission was under review Summary page 1.

## Indications for use
The Span-America Horizontal Low Air Loss Mattress System is a powered air flotation mattress with low air loss. The pressure-reducing surface is indicated for the prevention and treatment of pressure ulcers.

Source page: https://510kreport.com/device/K961159
Methodology: https://510kreport.com/methodology