21 CFR § 870.3640 - Indirect pacemaker generator function analyzer.

---
identifier: "/us/cfr/t21/s870.3640"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 870.3640 - Indirect pacemaker generator function analyzer."
title_number: 21
title_name: "Food and Drugs"
section_number: "870.3640"
section_name: "Indirect pacemaker generator function analyzer."
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"
---


# 870.3640 Indirect pacemaker generator function analyzer.

(a) *Identification.* An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or pacemaker battery function by periodically monitoring an implanted pacemaker's pulse rate and pulse width. The device is noninvasive, and it detects pacemaker pulse rate and width via external electrodes in contact with the patient's skin.

(b) *Classification.* Class II (performance standards).