(a) Identification. A skin potential measurement device is a general diagnostic device used to measure skin voltage by means of surface skin electrodes.

(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.

[44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019]