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Pacetrak Plus

FDA 510(k)

Class II (US FDA 510(k))

510(k) K954495

by Universal Medical, Inc.

Identifiers

510(k) Number
K954495 FDA 510(k)
FDA Product Code
DXH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2920 FDA 510(k)
Regulation Number
870.2920 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Pacetrak Plus is a Transmitter and Receiver, Electrocardiograph, Telephone, designed to facilitate remote monitoring of electrocardiographic (ECG) signals. It enables real-time transmission of cardiac data over telephone lines, allowing clinicians to assess patient heart rhythms from a distance without requiring in-person evaluation.

This device is intended for single-use or reusable applications in clinical settings, depending on manufacturer guidelines. Supplied as a Class II medical device under FDA 510(k) clearance (K954495), it operates within standard telephone infrastructure and does not require MRI compatibility. Storage and handling follow standard medical device protocols, with no specified sterility requirements beyond typical pre-procedure cleaning. Authorizations are governed by the FDA’s regulatory framework for cardiovascular monitoring devices.

Frequently asked questions

What is the primary purpose of the Pacetrak Plus and how does it differ from traditional ECG monitoring?

The Pacetrak Plus is designed to remotely transmit electrocardiographic (ECG) signals in real-time over standard telephone lines, allowing clinicians to monitor a patient’s heart rhythm without needing to be physically present. Unlike traditional ECG monitors that require on-site interpretation, this device enables remote assessment, which is particularly useful for continuous or intermittent cardiac monitoring in clinical settings where immediate evaluation may not be feasible.

Is the Pacetrak Plus intended for single-use or reusable applications, and what are the manufacturer’s guidelines?

The Pacetrak Plus is designed for both single-use and reusable applications, though the manufacturer’s guidelines dictate whether reuse is appropriate based on usage conditions and cleaning protocols. Since no specific sterility requirements beyond standard pre-procedure cleaning are mentioned, reuse should follow established medical device reprocessing standards to ensure safety and functionality.

What telephone infrastructure compatibility does the Pacetrak Plus require, and does it have any special considerations for use?

The Pacetrak Plus operates within standard telephone infrastructure, meaning it does not require specialized lines or equipment beyond a typical phone connection. There are no noted restrictions like MRI compatibility, so it can be used in non-MRI environments without interference concerns. However, compatibility with modern digital phone systems should be verified, as older analog lines may be required for optimal performance.

How do I determine which model or variant of the Pacetrak Plus is right for my clinical setting?

The Pacetrak Plus comes in multiple FEI (Final Establishment Identification) numbers, indicating different lot or variant configurations (e.g., 3013689228, 3011265784, etc.). While the exact specifications for each variant aren’t detailed here, the device is classified under product code DXH for transmitters/receivers in cardiovascular monitoring. Contacting Universal Medical, Inc. directly would provide clarity on which variant aligns with your facility’s needs, such as batch size, additional features, or compatibility with specific telephony systems.

Are there any special storage or handling requirements for the Pacetrak Plus beyond standard medical device protocols?

The Pacetrak Plus follows standard medical device storage and handling protocols, with no additional specifications provided beyond typical pre-procedure cleaning. Since it is not classified as sterile, routine disinfection between uses (if reusable) should adhere to manufacturer-recommended practices to prevent cross-contamination. Environmental conditions like temperature and humidity should also align with general medical device storage guidelines to maintain functionality.

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: Pacetrak Plus 510 (k) FDA Premarket Notification K954495 UNIVERSAL ..., UNIVERSAL MEDICAL, INC. Pacetrak Plus Rev 5 (PP5-Pactrak Plus ENR ..., PACETRAK PLUS (K954495) — FDA 510(k) | Innolitics, UNIVERSAL MEDICAL, INC. - RevMed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Universal Medical, Inc.

Sources (1)

  • FDA 510(k) K954495 24 fields · synced Sep 19, 2026