(a)Identification. A manual algesimeter is a mechanical device intended to determine a patient's sensitivity to pain after administration of an anesthetic agent, e.g., by pricking with a sharp point.
(b)Classification. Class I (general 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. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.
[54 FR 25048, June 12, 1989, as amended at 66 FR 38793, July 25, 2001]