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Mortara Stress Echo Bed

FDA 510(k)

Class II (US FDA 510(k))

510(k) K082967

by Medical Positioning, Inc.

Identifiers

510(k) Number
K082967 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 Mortara Stress Echo Bed is a medical positioning device designed for stress echocardiography examinations. It provides a controlled exercise source with programmable, variable resistance to facilitate imaging of cardiac structures during peak exercise, supporting diagnostic assessments in cardiology.

This device is supplied as a reusable medical positioning system and is intended for use in clinical settings such as cardiac laboratories. It features an adjustable, removable ergometer with a patient weight capacity of up to 500 lbs. The device holds FDA 510(k) clearance (K082967) under the Special 510(k) pathway, classified under the Cardiovascular advisory committee and product code DPS.

Frequently asked questions

What types of clinical settings is the Mortara Stress Echo Bed intended for use in?

The Mortara Stress Echo Bed is designed specifically for cardiac laboratories where stress echocardiography examinations are performed. Its reusable medical positioning system and ergometer are engineered to support controlled exercise testing, making it ideal for cardiology departments focused on diagnostic cardiac assessments during peak exercise.

How much weight can the Mortara Stress Echo Bed support, and is it adjustable?

The device is built to accommodate patients weighing up to 500 lbs. It includes an adjustable, removable ergometer, allowing clinicians to customize the positioning and resistance settings for individual patient needs during stress echocardiography.

Is the Mortara Stress Echo Bed intended for single-use or reusable applications?

The Mortara Stress Echo Bed is explicitly described as a reusable medical positioning system, meaning it is designed for repeated use in clinical settings after proper cleaning and maintenance.

What regulatory pathway was followed for the Mortara Stress Echo Bed’s FDA clearance?

The Mortara Stress Echo Bed received FDA clearance under the Special 510(k) pathway, classified under the Cardiovascular advisory committee (CV) and assigned product code DPS. This pathway was used to demonstrate substantial equivalence to a predicate device.

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, MORTARA STRESS ECHO BED by MEDICAL POSITIONING, INC. | FDA 510 (k) Summary, MORTARA STRESS ECHO BED by MEDICAL POSITIONING, INC. | FDA 510 (k) Summary

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) K082967 24 fields · synced Sep 18, 2026