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510(k) Data Aggregation
K Number
K013458Device Name
CRANIAL HELMET
Manufacturer
Date Cleared
2001-10-29
(11 days)
Product Code
Regulation Number
882.5970Why did this record match?
Applicant Name (Manufacturer) :
CHILDREN'S HOSPITAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Children's Hospital cranial helmet is intended to apply passive pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from three to eighteen months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
Device Description
The Children's Hospital cranial helmet is a cranial orthosis for the treatment of deformational plagiocephaly. It is a lightweight, semi-rigid plastic helmet with a foam lining. Each helmet is assembled individually, with some areas that fit snugly to the child's head, and with other recessed areas. As the child's brain grows, the skull is slowly reshaped and rounded by growing into the recessed areas.
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K Number
K003035Device Name
CLARREN HELMET
Manufacturer
Date Cleared
2001-06-06
(251 days)
Product Code
Regulation Number
882.5970Why did this record match?
Applicant Name (Manufacturer) :
CHILDREN'S HOSPITAL & MEDICAL CENTER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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