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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
SLEEP SPECIALISTS, LLC
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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