# K970364: AIRTEC2 Low Air Loss Therapy Bed

- Pathway: 510(k) (Traditional)
- Applicant: Apex Metal, Inc.
- Decided: Nov 17, 1997 after 290 days
- Product code: IOQ (Bed, Flotation Therapy, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5170
- 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 Apex Metal AirTec2 Low Air Loss Therapy Bed is indicated for pressure relief for patients with pressure sores, burns, amputations, shin flap or graft surgery, that may be in Neurology, Dermatology, Rehabilitation or Orthopedics. | For pain (] management and pressure relief consider the AerecZ for patlents with arthrms, A]])S or cancer. T

Source page: https://510kreport.com/device/K970364
Methodology: https://510kreport.com/methodology