1-800-Tongues, Inc.

1-800-Tongues, Inc. specializes in oral hygiene devices. Specifically, they produce the TONGUE CLEAN, a device designed to remove debris and bacteria from the tongue surface. This product falls under the category of medical devices intended for improving oral health.

1-800-Tongues, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The TONGUE CLEAN is classified under Class I, which typically involves less stringent regulatory controls compared to higher-risk devices, but compliance with FDA requirements remains mandatory.

The TONGUE CLEAN is classified as a Class I medical device by the FDA. This classification is based on its intended use—removing debris from the tongue—and its low risk profile. Class I devices generally pose minimal potential harm to users, so they often follow simplified regulatory pathways like the 510(k) clearance process to demonstrate substantial equivalence to a legally marketed predicate device.

The TONGUE CLEAN is listed in the FDA’s 510(k) database, which tracks devices that have undergone the 510(k) premarket notification process. This registry helps healthcare professionals, regulators, and other stakeholders verify that the device meets FDA requirements for market authorization before being sold in the U.S.