21 CFR 874.3375
§ 874.3375 Battery-powered artificial larynx.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 874.3375, § 874.3375 Battery-powered artificial larynx, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90216
- Permanent ID
ys:prov:90216@1- SHA-256
5024605fd4ad2783e92e3c0d0b03f35b3eb334fbe654d63af1ae4970e8c713ab
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Full text
(a) Identification. A battery-powered artificial larynx is an externally applied device intended for use in the absence of the larynx to produce sound. When held against the skin in the area of the voicebox, the device generates mechanical vibrations which resonate in the oral and nasal cavities and can be modulated by the tongue and lips in a normal manner, thereby allowing the production of speech.
(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 § 874.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.