📋 FDA Reference
External Pacemaker Analyzer Model Pma-1
Bio-Tek Instruments
Summary: The external pacemaker analyzer model PMA-1 by Bio-Tek Instruments is a device used to test and analyze the function of external pacemakers. It is primarily used by cardiologists and biomedical technicians in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K903966 ↗
Decision Date ?
June 19, 1991
Product Code ?
DTC
Device Class ?
Class 2
Evidence ?
0 studies
The external pacemaker analyzer model PMA-1 was cleared through the FDA 510(k) pathway on June 19, 1991. Manufactured by Bio-Tek Instruments, it is classified as a Class 2 medical device under product code DTC.
What It Is
The external pacemaker analyzer model PMA-1 is a diagnostic tool designed to evaluate the performance and functionality of external pacemakers. It measures parameters such as pulse rate, amplitude, and duration to ensure the pacemaker is functioning correctly. This device is essential for verifying the operational status of pacemakers before they are used on patients, ensuring safety and efficacy.
FDA-Cleared Indications
- Testing and analyzing the performance of external pacemakers.
- Measuring external pacemaker parameters such as pulse rate, amplitude, and pulse duration.
- Verifying that an external pacemaker is operating within expected performance specifications.
Clinical Applications
- Bench testing of external pacemakers before clinical use.
- Routine performance checks of external pacemaker systems in hospitals and cardiac care settings.
- Troubleshooting suspected external pacemaker malfunction.
- Biomedical equipment testing and maintenance of external pacemakers.
Practical Considerations
- Use requires trained personnel familiar with external pacemakers, electrical safety, and biomedical equipment testing.
- Compatibility depends on the external pacemaker, connector configuration, and electrical specifications; confirm connections before testing.
- The analyzer evaluates pacemaker output and does not replace patient monitoring, clinical assessment, or manufacturer-specific testing requirements.
- The available FDA record does not establish MRI safety or MRI compatibility; do not use the analyzer in an MRI environment unless current manufacturer documentation specifically permits it.
- This is a diagnostic and testing instrument, not an implanted pacemaker or a therapeutic pacing device.
Frequently Asked Questions
What is the external pacemaker analyzer model PMA-1 used for?
It is used to test and analyze the function of external pacemakers, ensuring they operate correctly before patient use.
What specialties typically use this device?
Cardiologists and biomedical technicians in hospitals and clinics typically use this device.
What are the FDA-cleared indications?
The device is indicated for testing and verifying the performance of external pacemakers in clinical settings.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.