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510(k) Data Aggregation
K Number
K180124Device Name
ZQuiet
Manufacturer
Sleeping Well,LLC
Date Cleared
2018-06-12
(147 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Sleeping Well,LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ZQuiet is intended as an aid in the reduction of snoring for adults at least 18 years old.
Device Description
The ZQuiet is an oral appliance comprised of an upper and lower tray constructed in one piece and joined by a flexible hinge. The trays engage with the maxillary and mandibular dentition and the device maintains an anterior positioning of the mandible which widens the pharyngeal airway to prevent occlusion. The device is presented in varying protrusive sizes allowing the user to try different degrees of mandibular advancement to reduce snoring.
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