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ZQuiet

FDA 510(k)

Class II (US FDA 510(k))

510(k) K180124

by Sleeping Well, LLC

Identifiers

510(k) Number
K180124 FDA 510(k)
FDA Product Code
LRK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.5570 FDA 510(k)
Regulation Number
872.5570 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

ZQuiet is an anti-snoring device classified as an intraoral appliance. It is designed to treat nighttime snoring by addressing the source of the condition.

This device is regulated under FDA 510K authorization as a class 2 dental device. It is manufactured by Sleeping Well, LLC and is identified by product code LRK.

Frequently asked questions

What is the primary purpose of the ZQuiet device?

ZQuiet is an intraoral appliance specifically designed to treat nighttime snoring by addressing the source of the condition.

How is ZQuiet classified for regulatory purposes?

ZQuiet is regulated as a class 2 dental device under FDA 510K authorization, identified by product code LRK.

Who is the manufacturer of the ZQuiet device?

The device is manufactured by Sleeping Well, LLC, which is based in Shelburne, Vermont.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Shop Stop Snoring Solutions Guaranteed to Work for You | ZQuiet, Sleeping Well, LLC - Buzzfile, ERSP Finds Sleeping Well, LLC, Can Support Certain Claims for ZQuiet, Sleeping Well, LLC - Buzzfile

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sleeping Well, LLC

Sources (1)

  • FDA 510(k) K180124 24 fields · synced Oct 6, 2026