Intermedics Programmer Model 522-03

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K812813 ↗

FDA Product Code

KRG

Device Class

Class III

Regulation

21 CFR Part 870.3700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Intermedics, Inc. →

• What clinical environments is the Intermedics Programmer Model 522-03 designed for, and how does its reusable nature impact its use?

  The Intermedics Programmer Model 522-03 is specifically designed for clinical settings such as hospitals, electrophysiology labs, and cardiac care units, where implantable pacemakers and cardiac rhythm management devices are programmed, tested, and monitored. Since it is a reusable device, its use requires strict adherence to manufacturer guidelines for calibration and maintenance to ensure accurate programming and diagnostic functionality. This design ensures reliability in controlled environments where regular upkeep can be performed.

• How does the regulatory status of the Intermedics Programmer Model 522-03 affect its adoption or use in healthcare facilities?

  The Intermedics Programmer Model 522-03 holds an FDA 510(k) clearance under submission K812813, classified as substantially equivalent to a predicate device. This means it has undergone regulatory review to confirm its safety and effectiveness, providing healthcare facilities with confidence in its compliance with U.S. medical device regulations. Clinicians and administrators can rely on this clearance when integrating the device into their workflows, ensuring it meets established standards for programming and monitoring cardiac devices.

• What storage and handling precautions should be taken for the Intermedics Programmer Model 522-03 to maintain its functionality?

  The Intermedics Programmer Model 522-03 requires careful storage and handling to preserve its functionality, as outlined by the manufacturer. Since it is a reusable device, it must be stored in a clean, controlled environment to prevent contamination or damage. Regular calibration and maintenance are essential to ensure accurate programming and diagnostic capabilities, and any storage conditions should align with the manufacturer’s guidelines to avoid compromising performance.

• What types of cardiac devices can the Intermedics Programmer Model 522-03 be used to program, test, and monitor?

  The Intermedics Programmer Model 522-03 is designed to program, test, and monitor implantable pacemakers and related cardiac rhythm management devices. Its functionality allows clinicians to adjust pacing parameters and diagnose device function in real time, making it suitable for devices used in managing heart rhythms, such as single- and dual-chamber pacemakers or other implantable systems requiring precise programming.