Search Results
Found 1 results
510(k) Data Aggregation
K Number
K041996Device Name
NIGHTFORM
Manufacturer
Date Cleared
2004-08-03
(8 days)
Product Code
Regulation Number
880.5680Why did this record match?
Applicant Name (Manufacturer) :
PLASTIC SURGERY SOLUTIONS, LLC
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.
Ask a Question
Ask a specific question about this device
Page 1 of 1