Vivos Inc (RDGL)

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https://www.fda.gov/animalveterinary/resourcesforyou/ucm047117.htm

Pre-market Approval is Not Required: The FDA does not require submission of a 510(k), PMA, or any pre-market approval for devices used in veterinary medicine. Firms that manufacture radiation emitting devices need to register their products under the radiological health regulations, administered by the Center for Devices Radiological Health (CDRH).

Device manufacturers who exclusively manufacture or distribute veterinary devices are not required to register their establishments and list veterinary devices and are exempt from post-marketing reporting.

FDA does have regulatory oversight over veterinary devices and can take appropriate regulatory action if a veterinary device is misbranded or adulterated.

It is the responsibility of the manufacturer and/or distributor of these articles to assure that these animal devices are safe, effective, and properly labeled.