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Q-Stress Echo Bed

FDA 510(k)

Class II (US FDA 510(k))

510(k) K021171

by Medical Positioning, Inc.

Identifiers

510(k) Number
K021171 FDA 510(k)
FDA Product Code
DPS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2340 FDA 510(k)
Regulation Number
870.2340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Q-Stress Echo Bed is a patient positioning device designed for stress echocardiography, combining an adjustable ergometer with a bed frame to facilitate cardiac imaging during exercise. It provides a controlled exercise platform to assess cardiac function under stress conditions, enabling evaluation of arrhythmias or rate abnormalities via integrated electrocardiographic monitoring.

This device is used in clinical settings such as cardiology labs for stress testing and imaging. Supplied as a reusable medical instrument, it features a weight capacity of up to 500 lbs and an adjustable ergometer for variable resistance exercise. The Q-Stress Echo Bed holds an FDA 510(k) clearance under K021171, classified under product code DPS, and is intended for use in environments requiring precise patient positioning and cardiac monitoring.

Frequently asked questions

What types of clinical environments is the Q-Stress Echo Bed designed for, and how does it support stress echocardiography testing?

The Q-Stress Echo Bed is specifically designed for cardiology labs where stress echocardiography is performed. It combines an adjustable ergometer with a bed frame to allow patients to exercise safely while lying down, which is essential for cardiac imaging during stress testing. The integrated electrocardiographic monitoring capability helps clinicians evaluate cardiac function, arrhythmias, or rate abnormalities under controlled exercise conditions, ensuring precise patient positioning and real-time assessment.

Is the Q-Stress Echo Bed intended for single-use or reusable applications, and what is its weight capacity?

The Q-Stress Echo Bed is supplied as a reusable medical instrument, meaning it is built for repeated use in clinical settings. It is engineered to support patients weighing up to 500 lbs, making it suitable for a wide range of patients during stress echocardiography procedures.

How does the adjustable ergometer feature on the Q-Stress Echo Bed contribute to the stress testing process?

The adjustable ergometer on the Q-Stress Echo Bed allows clinicians to vary exercise resistance, enabling controlled and progressive stress on the patient’s cardiovascular system. This feature is critical for accurately assessing cardiac function under different levels of exertion, as it mimics real-world physical activity while ensuring safety and precision during imaging.

What regulatory pathway was followed for the Q-Stress Echo Bed, and which advisory committee reviewed its submission?

The Q-Stress Echo Bed received FDA clearance through a 510(k) submission, classified under product code DPS (Diagnostic, Patient Support). The submission was reviewed by the Cardiovascular (CV) Advisory Committee, and the device was determined to be substantially equivalent to a predicate device. The clearance was granted under the classification of a special 510(k) decision.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Stress EchoBed® - MedicalPositioning, Home - MedicalPositioning, Q-STRESS ECHO BED (K021171) — FDA 510 (k) | Innolitics, Q-stress Echo Bed 510 (k) FDA Premarket Notification K021171 MEDICAL ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medical Positioning, Inc.

Sources (1)

  • FDA 510(k) K021171 24 fields · synced Sep 18, 2026