Section 882.1500 - Esthesiometer(a)Identification. An esthesiometer is a mechanical device which usually consists of a single rod or fiber which is held in the fingers of the physician or other examiner and which is used to determine whether a patient has tactile sensitivity.(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 § 882.9 . 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 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319 , Jan. 14, 2000