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510(k) Data Aggregation
K Number
K214096Device Name
Respire Clear
Manufacturer
Respire Medical, LLC
Date Cleared
2022-05-31
(154 days)
Product Code
LRK, KMY, LQZ
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Respire Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Respire Clear is indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.
Device Description
The Respire Clear is an oral appliance used in the treatment of mild to moderate obstructive sleep apnea. This device helps move a patient's jaw forward, thus opening their airways, and allowing them to breathe more easily throughout the night. The Respire Clear is made out of dental industry standard 3D printed resins & metals, and is custom designed to fit each patients' unique oral anatomy.
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