StacksVerified U.S. regulatory reference

21 CFR §882.1320

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (a)Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
  2. (b)Classification. Class II (performance standards).