Stress Testing System, Multi-Position

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K790544 ↗

FDA Product Code

DRT

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• General Ultrasound Exam. Table

  Class II

  FDA 510(k) K802254 Active Cleared 26 Nov 1980

• Digital Radiography Examination Table

  Not classified

  FDA 510(k) K828313 Active Cleared 7 Oct 1982

• Non-Magnetic Examination Table for Magnetic Resona

  Class II

  FDA 510(k) K844578 Active Cleared 14 May 1985

• Universal Examination Table

  Class II

  FDA 510(k) K842108 Active Cleared 17 Jul 1984

• Stress Testing System, Lateral Tilting

  Class II

  FDA 510(k) K790545 Active Cleared 6 Jun 1979

• U-Mat

  Class I

  FDA 510(k) K790466 Active Cleared 28 Mar 1979

See all devices from Engineering Dynamics Corp. →

• What clinical settings is this stress testing system designed for and what conditions does it help diagnose?

  The Stress Testing System is specifically designed for use in clinical settings like hospitals and cardiac rehabilitation facilities. It is intended to evaluate cardiovascular function during graded exercise by monitoring heart rate, rhythm, and other physiological parameters. This helps clinicians assess patient responses to physical exertion, aiding in the diagnosis of coronary artery disease and other cardiac conditions.

• Is this device reusable, and what maintenance is required to ensure accurate performance?

  Yes, this Stress Testing System is supplied as a reusable device. To maintain accurate performance, it requires proper maintenance and calibration as outlined in the manufacturer’s instructions. Regular upkeep is essential to ensure reliable monitoring of heart rate, rhythm, and other physiological parameters during stress tests.

• How is the regulatory status of this device determined, and what does that mean for its use?

  This device has received FDA 510(k) clearance (K790544) and is classified as a Class II medical device under FDA regulations (870.2300). The clearance indicates it is substantially equivalent to predicate devices, meaning it meets the FDA’s requirements for safety and effectiveness for its intended use in evaluating cardiovascular function during stress testing.

• Does this system come in multiple sizes or models, and if so, how would I identify them?

  The device data includes multiple registration numbers (e.g., 3008717264, 3026751377) and product codes (DRT), which may correspond to different models or configurations of the Stress Testing System. While specific size or model details aren’t explicitly listed, these identifiers can be used to reference variations in the system’s design or capabilities. For precise model information, consult the manufacturer’s documentation or catalog.

• Is sterility or MRI safety information provided for this device, and what does that imply for its use?

  The provided data does not mention any specific sterility requirements or MRI safety information for this Stress Testing System. This implies that the device is not intended for sterile procedures or MRI-compatible use, and standard cleaning protocols (as outlined in maintenance guidelines) should be followed to ensure safe and hygienic operation in clinical settings.