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510(k) Data Aggregation
K Number
K082367Device Name
INFANT SLEEP BEANIE
Manufacturer
Date Cleared
2009-06-12
(298 days)
Product Code
Regulation Number
880.5680Why did this record match?
Product Code :
FRP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Life Innovations Infant Sleep Beanie is an over-thecounter repositioning device to aid in the prevention of deformational (or positional) plagiocephaly arising from consistent back-sleeping postures. The Infant Sleep Beanie is intended for healthy, non-ambulating infants 0-9 months of age.
Device Description
The Life Innovations Infant Sleep Beanie is a form fitting infant beanie hat placed strategically on a baby's head while lying awake, sleeping or during travel.
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K Number
K090284Device Name
RES-Q INFANT WEDGE AND SLING
Manufacturer
Date Cleared
2009-06-05
(120 days)
Product Code
Regulation Number
880.5680Why did this record match?
Product Code :
FRP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RES-Q Infant Wedge & Sling is designed to allow babies 0-12 months with gastroesophageal reflux to rest comfortably in a semi-upright position; it is used for sleeping and playtime in supine, prone, and side-lying positions.
Device Description
Device Name: RES-Q Infant Wedge & Sling
Classification/Common Name: Holder, Infant Positioner
Code FRP, CFR 880.5680
Class 1
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K Number
K062143Device Name
KOZY COMFORT INFANT POSITIONER
Manufacturer
Date Cleared
2006-10-24
(89 days)
Product Code
Regulation Number
880.5680Why did this record match?
Product Code :
FRP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Kozy Comfort product is indicated for healthy infants 0-12 months to aid in the prevention of skull deformities that may arise from consistent back-sleeping postures, namely the condition know as deformational (or positional) plagiocephaly
Device Description
Kozy Comfort™ Infant Positioner is a polyurethane based infant positioner.
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K Number
K060986Device Name
HEAD BED
Manufacturer
Date Cleared
2006-07-11
(92 days)
Product Code
Regulation Number
880.5680Why did this record match?
Product Code :
FRP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Head Bed™ infant positioner is indicated for infants aged 0-6 months to aid in the prevention of deformational plagiocephaly.
Device Description
The Head Bed device is a U-shaped soft polyurethane foam cushion covered in flame retardant cloth material. Outside dimensions are 17.5cm (w) x 18.5cm (1) x 4cm (h). Inside dimensions are 13.5cm (h) x 6.5cm (w). The device is adequately soft so as to provide support for the infants head without being abrasive. The removable cloth cover is flame retardant and machine washable.
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K Number
K051300Device Name
ROBIN HOOD VEST
Manufacturer
Date Cleared
2005-12-08
(204 days)
Product Code
Regulation Number
880.5680Why did this record match?
Product Code :
FRP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Robin Hood Vest ™ is intended for use in healthy infants aged 0-15 months to aid in the prevention of skull deformities that can arise from consistent back-sleeping postures, the condition known as deformational (or positional) plagiocephaly.
Device Description
The Robin Hood Vest ™ is a sleeveless vest, with a pocket on the back for an insertable foam wedge, that an infant wears while sleeping. The device positions a foam wedge under the infant during sleep to direct the head so that it does not always rest on the same spot.
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K Number
K041996Device Name
NIGHTFORM
Manufacturer
Date Cleared
2004-08-03
(8 days)
Product Code
Regulation Number
880.5680Why did this record match?
Product Code :
FRP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NightForm product is indicated for healthy infants 0-9 months to aid in the prevention of skull deformities that can rise from consistent back-sleeping postures, known as Deformational (or positional) plagiocephaly.
Device Description
NightForm is a fabric-covered polyurethane foam mattress with two accompanying fabric-covered polyurethane wedges that affix to the mattress by hook/loop fasteners in various positions that permit parents to modify nightly the supine sleeping position of their sleeping infants and thereby prevent a condition known as deformational plagiocephaly.
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K Number
K003511Device Name
KENDALL-LTP TURNER SAVE-A-LINE
Manufacturer
Date Cleared
2001-01-24
(71 days)
Product Code
Regulation Number
880.5680Why did this record match?
Product Code :
FRP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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