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510(k) Data Aggregation
K Number
K201719Device Name
Vital Sleep
Manufacturer
Date Cleared
2021-01-14
(205 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
The Snore Reliever Company, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Vital Sleep Device is intended as an aid in the reduction of snoring for adults at least 18-years old.
Device Description
The Vital Sleep Device is designed to pull the mandible forward by an adjustable distance, and keep the mouth slightly open during use and reduce snoring. It consists of an arch fitted over the upper teeth and one fitted over the lower teeth. The arches are connected by a flexible hinge that allows a lateral movement (pulling the mandible forward). The arches and hinges form one injection-molded poly-propylene part. In the manufacturing process the semi rigid substrate is over-molded with softer EVA material.
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