← Product Code [DRO](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO) · K864985

# DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE (K864985)

_Medac, Inc. · DRO · Mar 10, 1987 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K864985

## Device Facts

- **Applicant:** Medac, Inc.
- **Product Code:** [DRO](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO.md)
- **Decision Date:** Mar 10, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.5550
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles.

## Special Controls

*Classification.* Class II. The special controls for this device are:(1) “American National Standards Institute/American Association for Medical Instrumentation's DF-21 ‘Cardiac Defibrillator Devices’ ” 2d ed., 1996, and
(2) “The maximum pulse amplitude should not exceed 200 milliamperes. The maximum pulse duration should not exceed 50 milliseconds.”

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K864985](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K864985)

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