# K082967: Mortara Stress Echo Bed

- Pathway: 510(k) (Special)
- Applicant: Medical Positioning, Inc.
- Decided: Mar 26, 2009 after 171 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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 K002822 (2001). 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)
- K002822: Vertex System, Medical Positioning, Inc. (2001) Summary page 1.
- K021171: Q-Stress Echo Bed, Medical Positioning, Inc. (2002) Summary page 1.

## Indications for use
The M-Stress Echo TM Bed is intended for use in stress echocardiography examination. The M-Stress Echo TM Bed provides an exercise source that delivers programmable, controlled variable resistance. The M-Stress Echo TM Bed incorporates an electrocardiograph that records either normal conditions or patterns of arrhythmia and/or rate abnormalities in patients. In addition, the stress echo workstation provides "QRS" complex to a cardiac ultrasound device to be used to capture images (heart beats), either digitally or on videotape, such that each image begins at the time systole begins.

Source page: https://510kreport.com/device/K082967
Methodology: https://510kreport.com/methodology