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510(k) Data Aggregation

    K Number
    K103704
    Device Name
    REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP
    Manufacturer
    ZEPHYR SLEEP TECHNOLOGIES INC
    Date Cleared
    2012-03-23

    (459 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZEPHYR SLEEP TECHNOLOGIES INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Overnight use of a temporary oral appliance to determine in which patients with obstructive sleep apnea mandibular advancement by an oral appliance will reduce obstruction of airflow and thereby to identify patients suitable for oral appliance therapy. The device is also used to recommend a target mandibular position that will reduce obstruction of airflow in patients determined to be suitable for oral appliance therapy.
    Device Description
    The RCMP appliance is a device used in the clinical setting to identify patients with obstructive sleep apnea that will be successfully treated with an oral appliance. A temporary appliance fits to the patient's teeth and incrementally and reversibly advances the patient's mandible anteriorly with respect to the maxilla while the patient is under full polysomnographic monitoring. The repositioning of the mandible pulls the tongue forward and increases the patient's airway space. Such obstruction can be a causative factor in obstructive sleep apnea and snoring. The RCMP is used in the clinical setting by a technician to advance the mandible until the polysomnographic data indicates removal of the obstruction of airflow in the airway. The device is used to recommend a target mandibular position that will reduce obstruction of airflow in patients determined to be suitable for oral appliance therapy. The RCMP appliance consists of upper and lower disposable dental titration trays that are used to hold onto the teeth by means of a quick-set retention material. The trays attach to a mandibular positioner that retracts and extends a rod to adjust the tray positioning by means of a small force linear actuator. By extending the linear actuator rod attached to the upper tray, the RCMP pushes on the upper teeth and pulls on the lower teeth, thus displacing the jaw. RCMP software interacts with the polysomnography to allow the technician to control fine adjustments of the relative position of the mandible.
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