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510(k) Data Aggregation

    K Number
    K180608
    Device Name
    Lunoa System
    Manufacturer
    NightBalance BV
    Date Cleared
    2018-06-05

    (90 days)

    Product Code
    MYB
    Regulation Number
    872.5570
    Why did this record match?
    Product Code :

    MYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lunoa System is indicated for prescription use for the treatments with positional obstructive sleep apnea with a non-supine apnea-hypopnea index <20. It records position and movement so that positional changes in sleep quality can be assessed.
    Device Description
    The Lunoa System is a rechargeable battery-operated medical device, worn around the chest in an elasticized chest strap (Figure 1), intended to keep patients with positional obstructive sleep apnea (POSA) from sleeping in the supine position. The System consists of a sensor device, chest strap, docking station, power adapter, travel case, and portal.
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    K Number
    K140190
    Device Name
    NIGHT SHIFT
    Manufacturer
    ADVANCED BRAIN MONITORING, INC.
    Date Cleared
    2014-05-29

    (125 days)

    Product Code
    MYB, MNR
    Regulation Number
    872.5570
    Why did this record match?
    Product Code :

    MYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Night Shift is indicated for prescription use for the treatment of adult patients with positional obstructive sleep apnea with a non-supine apnea-hypopnea index < 20, and to reduce or alleviate snoring. It records position, movement, and sound so that positional changes in sleep quality and snoring can be assessed.
    Device Description
    The Night Shift is worn around the neck to reduce the amount of time the user sleeps in the supine position as a treatment for positional obstructive sleep apnea. Night Shift combines hardware and firmware to detect when the user attempts to sleep in the supine position and can initiate vibro-tactile feedback with increasing intensity until the user shifts to a non-supine position. The initiation of positional feedback from the Night Shift is turned on is programmable to allow the user to fall asleep (if they must) on their back. Each night the Night Shift is worn, it monitors sleep position (% time supine), behavioral sleep efficiency, and snoring levels (% time snoring > 40 and 50 dB) as well as the frequency, duration and intensity of the feedback (when applied). These data can be optionally transferred via the USB port to the Night Shift Web Portal where the user can generate a report to assess how well the positional feedback is working. A "trial" protocol can include one night with no feedback to establish a baseline and two nights with feedback to assess compliance/efficacy. Utilization information is saved on the device that allows reports to be generated that compares daily use by month and monthly averages for one year. The portal also allows the device to be reformatted (to eliminate all previously recorded data) for a new user, adjust the feedback settings to a new user's personal preferences, and/or upgrade the firmware. For large healthcare organizations that limit internet access, desktop software is provided as an alternative to the portal.
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    K Number
    K100160
    Device Name
    ZZOMA POSITIONAL SLEEPER MODEL 001
    Manufacturer
    SLEEP SPECIALISTS, LLC
    Date Cleared
    2010-05-11

    (111 days)

    Product Code
    MYB
    Regulation Number
    872.5570
    Why did this record match?
    Product Code :

    MYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZZOMA Positional Sleeper is indicated for use and intended for professional use for the treatment of mild to moderate, predominantly positional obstructive sleep apnea (OSA) and to reduce or alleviate snoring. The ZZOMA Positional Sleeper is intended for use by professional healthcare personnel trained in its use.
    Device Description
    The ZZOMA Positional Sleeper is 12 x 5.5 x 4 inches in size and made of lightweight semi-rigid synthetic foam (Figures 1 and 2). It is contained in a backpack type material with an associated Velcro® elastic belt. The device is worn on the back, with the elastic belts brought around each side of the subject and secured anteriorly with the adjustable straps. The particular size and wedge-shaped design on both sides of this device keeps the subject comfortably positioned on their side, and prevents him/her from assuming the supine position. The ZZOMA has a firm inner core made of foam and the outer part of the device is covered in nylon, and the part that touches the subject's body is cotton covered with a coating of PVC dots that help keep the ZZOMA in place while you sleep.
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    K Number
    K040161
    Device Name
    SONA PILLOW
    Manufacturer
    SLEEP DEVICES, INC.
    Date Cleared
    2004-04-30

    (98 days)

    Product Code
    MYB
    Regulation Number
    872.5570
    Why did this record match?
    Product Code :

    MYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1- MAY STOP OR DECREASE SNORING 2- MAY BE USED TO TREAT MILD OBSTRUCTIVE SLEEP APNEA 3- MAY IMPROVE THE QUALITY OF SLEEP
    Device Description
    Not Found
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    K Number
    K023010
    Device Name
    SNIFF POSITION PILLOWS/POPITZ PILLOWS
    Manufacturer
    AEOLUS INTERNATIONAL CORPORATION
    Date Cleared
    2002-10-01

    (22 days)

    Product Code
    MYB
    Regulation Number
    872.5570
    Why did this record match?
    Product Code :

    MYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sniff Position Pillows are indicated for the following uses: - 1.) May improve the quality of sleep - 2.) May improve the symptoms of mild obstructive sleep apnea - 3.) May improve snoring
    Device Description
    Not Found
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    K Number
    K990871
    Device Name
    PILLOWPOSITIVE CERVICAL PILLOW
    Manufacturer
    LIFESLEEP SYSTEMS, INC.
    Date Cleared
    1999-06-10

    (86 days)

    Product Code
    MYB
    Regulation Number
    872.5570
    Why did this record match?
    Product Code :

    MYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PillowPositive Cervical Pillow ("PillowPositive") is intended for the reduction of symptoms (apnea/hypopnea) associated with mild obstructive sleep apnea by maintaining an open upper airway during sleep. PillowPositive Cervical Pillow ("PillowPositive") is indicated for the reduction of symptoms (apneas and hypopneas) associated with mild obstructive sleep apnea.
    Device Description
    The pillow consists of a custom-fitted high resiliency urethane foundation, an overlying "memory foam" supporting the head and neck, a stretch terry-cloth cover, and removable foam inserts. The PillowPositive is comprised of a thin central area for supine sleeping and two thicker, sloped side panels with earwells for side sleeping.
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