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510(k) Data Aggregation
K Number
K181396Device Name
Oral Device OA, Oral Device S
Manufacturer
Passion for Life Healthcare (UK) Limited
Date Cleared
2018-11-16
(171 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Passion for Life Healthcare (UK) Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Oral Device-OA is intended to reduce night-time snoring and / or mild to moderate obstructive sleep apnea (OSA) for adults 18 and older.
The Oral Device-S is intended to reduce night time snoring for adults 18 and older.
Device Description
Passion for Life Healthcare UK Limited is offering two devices: 1) the Oral Device-S is an OTC device intended as an aid for the reduction of snoring; and 2) the Oral Device-OA is a Rx device intended as an aid for the reduction of mild to moderate obstructive sleep apnea, and/or snoring.
Both the Oral Device-S and Oral Device-OA are an oral appliance design concept based upon the use of a standard set of upper and lower trays of one size.
The Oral Device-OA is fitted by a dentist to act as a Mandibular Repositioning Device (MRD).
Whereas the Oral Device-S, an OTC device, is fitted by the user at home and any adjustments can be made without clinician interaction.
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