Title 21

SECTION 882.1561

882.1561 Evoked photon image capture device.

§ 882.1561 Evoked photon image capture device.

(a) Identification. An evoked photon image capture device is a prescription, electrically powered device intended for use as a noninvasive measurement tool that applies electricity to detect electrophysiological signals emanating from the skin, which are reported numerically and as images without clinical interpretation. The device is not intended for diagnostic purposes.

(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 § 882.9.

[81 FR 67155, Sept. 30, 2016]