Model 725TH Handheld Transceiver (Programmer)

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

510(k) Number

K863582 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What clinical setting is the Model 725TH Handheld Transceiver primarily intended for use in, and why is this important for clinicians?

  The Model 725TH is designed for use in clinical settings such as hospitals and cardiac care units. This is important because it ensures compatibility with environments where implantable pacemakers are commonly managed, allowing clinicians to program, interrogate, and adjust pacing parameters in controlled, sterile conditions where patient safety is prioritized.

• Is the Model 725TH Handheld Transceiver a single-use or reusable device, and what does this mean for maintenance and cost considerations?

  The Model 725TH is explicitly described as a reusable medical instrument. This means it is built for repeated use in clinical settings, reducing single-patient disposal costs and requiring proper cleaning, disinfection, and maintenance protocols to ensure reliability and infection control over time.

• How does the Model 725TH Handheld Transceiver communicate with implantable pacemakers, and what types of adjustments can clinicians make?

  The Model 725TH is a transceiver designed to wirelessly communicate with implantable pacemakers, enabling clinicians to program settings, interrogate device data (e.g., pacing parameters, battery status), and transfer information for assessment. This allows for real-time adjustments to pacing rhythms, rate responses, and other cardiac parameters critical for patient management.

• What regulatory pathway was followed for FDA clearance of the Model 725TH, and how does this affect its use in clinical practice?

  The Model 725TH received FDA clearance via a 510(k) submission (K863582), determined to be *substantially equivalent* to a predicate device under the Cardiovascular (CV) advisory committee. This means it meets FDA standards for safety and effectiveness as a pulse-generator transceiver, ensuring clinicians can rely on it for programming and monitoring implantable pacemakers in accordance with U.S. regulatory requirements.

• Are there any specific storage requirements mentioned for the Model 725TH Handheld Transceiver, and why might this matter for hospitals?

  The provided data does not specify storage conditions (e.g., temperature, humidity) or environmental requirements for the Model 725TH. For hospitals, this means storage protocols should align with general medical device guidelines—such as protecting against physical damage, electrostatic discharge, and contamination—to maintain functionality and ensure reliable performance during clinical use.