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510(k) Data Aggregation
K Number
K081965Device Name
MPOWRX SNORING SOLUTION
Manufacturer
Date Cleared
2008-10-27
(109 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
MPOWRX HEALTH AND WELLNESS PRODUCTS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MPowRx™ Snoring Solution is intended for the treatment of mild to moderate snoring.
Device Description
The MPowRxTM Snoring Solution is a simple one-piece, one-size-fits-all oral appliance used to prevent mild to moderate snoring. The MPowRx™ Snoring Solution is comfortably retained within the mouth while sleeping.
The MPowRx™ Snoring Solution is fabricated from a common oral appliance material, fits between the lips and teeth, and has an aperture with a protrusion for holding the tongue. Once the protrusion is squeezed to reduce the air volume, a vacuum is formed which keeps the tongue comfortably retained within the protrusion. Forward retention of the tongue helps keep the upper respiratory air passages open to relieve snoring.
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