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Found 6 results
510(k) Data Aggregation
K Number
K180608Device Name
Lunoa System
Manufacturer
NightBalance BV
Date Cleared
2018-06-05
(90 days)
Product Code
MYB
Regulation Number
872.5570Why 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
K140190Device Name
NIGHT SHIFT
Manufacturer
ADVANCED BRAIN MONITORING, INC.
Date Cleared
2014-05-29
(125 days)
Product Code
MYB, MNR
Regulation Number
872.5570Why 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
K100160Device Name
ZZOMA POSITIONAL SLEEPER MODEL 001
Manufacturer
SLEEP SPECIALISTS, LLC
Date Cleared
2010-05-11
(111 days)
Product Code
MYB
Regulation Number
872.5570Why 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
K040161Device Name
SONA PILLOW
Manufacturer
SLEEP DEVICES, INC.
Date Cleared
2004-04-30
(98 days)
Product Code
MYB
Regulation Number
872.5570Why 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
K023010Device Name
SNIFF POSITION PILLOWS/POPITZ PILLOWS
Manufacturer
AEOLUS INTERNATIONAL CORPORATION
Date Cleared
2002-10-01
(22 days)
Product Code
MYB
Regulation Number
872.5570Why 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
K990871Device Name
PILLOWPOSITIVE CERVICAL PILLOW
Manufacturer
LIFESLEEP SYSTEMS, INC.
Date Cleared
1999-06-10
(86 days)
Product Code
MYB
Regulation Number
872.5570Why 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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