CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 882—NEUROLOGICAL DEVICES > SUBPART B—Neurological Diagnostic Devices (§882.1020 to §882.1950) > 882.1350—Needle electrode.

882.1350—Needle electrode.

(a) Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.
(b) Classification. Class II (performance standards).