21 CFR 882.1561
§ 882.1561 Evoked photon image capture device.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 882.1561, § 882.1561 Evoked photon image capture device, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90654
- Permanent ID
ys:prov:90654@1- SHA-256
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.