eCFR Reference Browser

---

title: "21 CFR §890.1385"

source: "https://www.ecfr.gov/current/title-21/section-890.1385"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "890"

part_subject: "PHYSICAL MEDICINE DEVICES"

subpart_code: "B"

subpart_subject: "Physical Medicine Diagnostic Devices"

section_number: "890.1385"

section_subject: "Diagnostic electromyograph needle electrode."

cfr_reference: "21 CFR 890.1385"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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).

§890.1385 - Diagnostic electromyograph needle electrode.