21 CFR § 870.5550 - External transcutaneous cardiac pacemaker (noninvasive).
---
identifier: "/us/cfr/t21/s870.5550"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 870.5550 - External transcutaneous cardiac pacemaker (noninvasive)."
title_number: 21
title_name: "Food and Drugs"
section_number: "870.5550"
section_name: "External transcutaneous cardiac pacemaker (noninvasive)."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "870"
part_name: "CARDIOVASCULAR DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "45 FR 7907, Feb. 5, 1980, unless otherwise noted."
cfr_part: "870"
---
# 870.5550 External transcutaneous cardiac pacemaker (noninvasive).
(a) *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.
(b) *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.”
[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 65 FR 17144, Mar. 31, 2000]