21 CFR § 890.1385 - Diagnostic electromyograph needle electrode.

---
identifier: "/us/cfr/t21/s890.1385"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 890.1385 - Diagnostic electromyograph needle electrode."
title_number: 21
title_name: "Food and Drugs"
section_number: "890.1385"
section_name: "Diagnostic electromyograph needle electrode."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "890"
part_name: "PHYSICAL MEDICINE 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: "48 FR 53047, Nov. 23, 1983, unless otherwise noted."
cfr_part: "890"
---


# 890.1385 Diagnostic electromyograph needle electrode.

(a) *Identification.* A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).

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