# K961009: Stresswriter Exercise Testing System

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard Co.
- Decided: Jun 17, 1996 after 97 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- 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. The FDA summary names its predicate without a number.
- (no number) M2488A StressWriter Exercise Testing System: named in the summary without a submission number

## Indications for use
The intended use of the M2488A HP StressWriter Exercise Testing System is to produce accurate measurements of the heart's response to exertion. Exercise electrocardiography is a commonly used non-invasive technique used to help detect coronary artery disease. This type of diagnostic tool can assist a physician in two important ways: - Report ECG changes which may indicate whether coronary circulation is able to increase the oxygen supply to muscle tissue in response to increased demand. - Assess the patient's overall exercise capacity. Typical applications of exercise electrocardiography could include the following: - Evaluating patients with symptoms suggestive of coronary disease - Determining the prognosis and severity of coronary disease - Evaluating the effects of medical and surgical therapy - Screening for latent coronary disease - Evaluating patients with stable congestive heart failure - Evaluating patients with arrhythmias - Evaluating the patient's functional capacity, and developing exercise prescriptions - Evaluating patients with congenital heart disease - Evaluating patients with exertional shortness of breath, dizziness, or syncope - Evaluating cardiac rehabilitation - Evaluating patients with rate-responsive pacemakers - Evaluating sports medicine patients Physicians typically evaluate the electrocardiogram for ST segment depression or elevation and or QRS alterations. This information is used by a physician in conjunction with other clinical information to diagnose and provide treatment.

Source page: https://510kreport.com/device/K961009
Methodology: https://510kreport.com/methodology