Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5550](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5550) → MPE — Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker

# MPE · Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker

_Cardiovascular · 21 CFR 870.5550 · Class 2_

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

## Overview

- **Product Code:** MPE
- **Device Name:** Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker
- **Regulation:** [21 CFR 870.5550](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5550)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **Life-sustaining:** yes

## 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.

## Classification Rationale

Class II. The special controls for this device are:

## 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.”

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K945511](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/MPE/K945511.md) | LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR | Physio-Control Corp. | Sep 26, 1995 | SESE |

## Top Applicants

- Physio-Control Corp. — 1 clearance

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

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