StacksVerified U.S. regulatory reference

21 CFR §882.1350

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.
  2. (b)Classification. Class II (performance standards).