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Transmitter & Receivers, Telephone, Elec

by Heart Check Systems, Inc.

510(k) K810608

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK810608 Date1 May 1981ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXH
Device Class
Class II
Regulation
21 CFR Part 870.2920
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is an electromagnetic transmitter and receiver system designed for electrocardiograph (ECG) monitoring via telephone lines. It facilitates remote transmission of cardiac signals between a patient’s ECG device and a healthcare provider, enabling real-time or delayed diagnostic assessment.

The system is intended for use in clinical or home settings, supplied as a reusable electronic unit with telephone connectivity. It operates under FDA 510(k) clearance (K810608) and falls under Device Class II (DXH). No sterility or MRI safety specifications are noted; compatibility with telephone infrastructure is required. Multiple model/registration numbers (e.g., 3013689228) identify variants, but no size or storage instructions are provided in the regulatory data.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical setting is this device designed for, and how does it function in those environments?

    This device is designed for use in both clinical and home settings, enabling remote ECG monitoring by transmitting cardiac signals over telephone lines. It connects a patient’s ECG device to a healthcare provider, allowing real-time or delayed diagnostic assessment without requiring physical presence. The system relies on standard telephone infrastructure, making it suitable for environments where telecommunication access is available.

  • Is this device single-use or reusable, and what are the implications for maintenance or replacement?

    The device is explicitly described as a reusable electronic unit, meaning it is intended for repeated use across multiple patients or monitoring sessions. Since it is not sterile and lacks MRI safety specifications, maintenance should follow manufacturer guidelines for electronic equipment, including periodic inspections, cleaning, and potential firmware updates. Replacement parts or updated models may be required over time, depending on wear or technological advancements.

  • How do I determine which model or variant of this device I am purchasing, given the multiple registration numbers listed?

    The device comes in multiple variants, each identified by unique registration numbers (e.g., 3013689228, 3011265784). These numbers correspond to different models or revisions but serve the same core function of transmitting ECG signals via telephone. To ensure compatibility, verify the registration number on the device against your records or consult the manufacturer’s documentation. The exact specifications (e.g., connectivity features, software versions) may vary by model, so alignment with your existing infrastructure is critical.

  • Does this device require any special storage conditions, and what should I consider when storing it?

    The regulatory data does not specify storage instructions for this device, but as a reusable electronic unit, it should be stored in a clean, dry environment protected from physical damage, extreme temperatures, or humidity. Avoid exposure to dust, moisture, or direct sunlight. Since it relies on telephone connectivity, ensure the storage area remains accessible for maintenance or updates. Always follow the manufacturer’s guidelines if additional storage precautions are provided.

  • What regulatory pathway was followed for this device, and how does that affect its use or limitations?

    This device was cleared through the FDA’s 510(k) pathway under the classification of Device Class II (DXH), with a decision of