StacksVerified U.S. regulatory reference

21 CFR §882.1560

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. A skin potential measurement device is a general diagnostic device used to measure skin voltage by means of surface skin electrodes.
  2. (b)Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.