---
kind: "section"
citation: "21 C.F.R. § 870.5550"
title: "21"
number: "870.5550"
heading: "External transcutaneous cardiac pacemaker (noninvasive)."
url: "https://uscodex.org/cfr/21/870.5550"
---

# §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.”

## Notes

### Amendments

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 65 FR 17144, Mar. 31, 2000]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

### Amendments

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 65 FR 17144, Mar. 31, 2000]