# K974070: Physio/1000

- Pathway: 510(k) (Traditional)
- Applicant: Physio Designs, Inc.
- Decided: Jan 6, 1998 after 70 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The intended use of this product is for the healing of Decubitus Ulcers through the minimization of chronic localized occlusive pressures.

Source page: https://510kreport.com/device/K974070
Methodology: https://510kreport.com/methodology