21 CFR 870.5550 — Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

Cardiovascular (CV) · Part 870 Subpart F—Cardiovascular Therapeutic Devices · § 870.5550

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:

Product Codes

Special Controls

DRO — Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

*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.”

eCFR

DRO — Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

(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.”

Ecfr Llm

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

*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.”

eCFR