# K082173: Q-Stress and Heartstride, Models Qstress/Q40 and H4/H4S

- Pathway: 510(k) (Special)
- Applicant: Cardiac Science Corporation
- Decided: Aug 26, 2008 after 25 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001492 (2000). 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)
- K001492: Quinton Q-Stress, Model 000483, Quinton, Inc. (2000) Summary page 1.

## Recalls of this device
- Mar 30, 2009 · Not classified · Z-1757-2010: 28 stress and rehab treadmills manufactured between September 2006 and January 2009 may not have received adequate electrical safety testing prior to being shipped from the factory. If these component

## Indications for use
The device is intended to acquire, process, record, archive, analyze, and output electrocardiographic data during physiologic stress testing. The device may interface with external devices, including a treadmill or ergometer for dynamic exercise evaluation, non-invasive blood pressure equipment, and computer communications equipment. The device is intended for use in a clinical setting by trained personnel under the supervision of a licensed physician. The device is intended for adult populations, typically symptomatic. The device is not intended to be used as a vital signs physiological monitor.

Source page: https://510kreport.com/device/K082173
Methodology: https://510kreport.com/methodology