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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
LIFESLEEP SYSTEMS, INC.
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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