StacksVerified U.S. regulatory reference

21 CFR §868.1040

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. A powered algesimeter is a device using electrical stimulation intended to determine a patient's sensitivity to pain after administration of an anesthetic agent.
  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 § 868.9.