EKG Transmitter Model 5134

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

510(k) Number

K842051 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Compressar Disposable Disc

  Class II

  FDA 510(k) K831337 Active Cleared 19 Jul 1983

• Lifesigns Receiving Cener 2000 Transtelephonic Receiver

  Class II

  FDA 510(k) K951096 Active Cleared 16 Jan 1996

• Self Check

  Class II

  FDA 510(k) K791762 Active Cleared 21 Sep 1979

• Compressar Universal (Tm) System

  Class II

  FDA 510(k) K925809 Active Cleared 22 Feb 1993

• Accelerated Transmission Protocol

  Class II

  FDA 510(k) K955060 Active Cleared 8 Apr 1996

• King of Hearts Express (E.X.) Monitor

  Class II

  FDA 510(k) K920984 Active Cleared 14 Oct 1992

See all devices from Instromedix, Inc. →

• Is the EKG Transmitter Model 5134 designed for single-use or can it be reused in clinical settings?

  The EKG Transmitter Model 5134 is explicitly described as a reusable medical instrument. This classification aligns with its regulatory submission as a Class 3 Cardiovascular device, where durability and repeated use are implied for clinical monitoring applications. Reusability is common for wireless transmitters in settings requiring continuous or intermittent cardiac monitoring, as it reduces costs and waste while maintaining reliability.

• What types of cardiac monitoring scenarios is the EKG Transmitter Model 5134 intended for, and how does it facilitate diagnostics?

  The device is designed for clinical settings where continuous or intermittent cardiac monitoring is required. It captures cardiac electrical activity from electrodes and wirelessly transmits the electrocardiogram (ECG/EKG) signals for remote monitoring or recording. This enables diagnostic assessment of heart function by allowing healthcare providers to analyze rhythm, rate, and potential abnormalities without direct physical connection to the patient, improving patient mobility and convenience.

• How is the EKG Transmitter Model 5134 regulated, and what does its FDA clearance status mean for its use?

  The EKG Transmitter Model 5134 is regulated under FDA 510(k) clearance (K842051) with a decision of *Substantially Equivalent* to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards for Class 3 Cardiovascular devices. Its clearance under regulation 870.3610 confirms compliance with FDA requirements for wireless ECG transmitters, allowing its use in clinical environments for cardiac monitoring.

• What should I consider when storing the EKG Transmitter Model 5134 to maintain its performance and sterility?

  While the device is reusable, its storage requirements are not explicitly detailed in the provided data. For reusable medical devices, best practices typically include clean, dry environments protected from dust, moisture, and extreme temperatures. Since it is not described as sterile (as it is reusable), routine cleaning and disinfection protocols per manufacturer guidelines would be essential to prevent contamination between uses. Always refer to the manufacturer’s instructions for specific storage and maintenance procedures.