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510(k) Data Aggregation
K Number
K022273Device Name
CRANIAL SYMMETRY SYSTEM
Manufacturer
Date Cleared
2002-09-09
(56 days)
Product Code
Regulation Number
882.5970Why did this record match?
Applicant Name (Manufacturer) :
BEVERLY HILLS PROSTHETICS ORTHOTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' three to eighteen months of age, with moderate to severe non-synostotic positional plagiocephaly, including infants' with plagiocephalic and brachycephalic shaped heads.
The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' 3 to 18 months of age, with plagiocephalic and brachycephalic shaped heads.
The sale and distribution of the device is restricted to prescription use in accordance with 21CFR801.109
Device Description
The Cranial Symmetry System provides passive pressure to the prominent areas of the infants' skull while allowing for growth into the flattened areas. There are no exceeding pressures that could put restrictions on brain growth. The cranial orthosis helmet is custom fabricated with lightweight materials. The outer shell consists of a sheet of three-sixteenths inch thick polypropylene. The padded inner liner consists of three-sixteenths Aliplast. These materials are vacuumed formed over the modified plaster cast mold of the infants' skull. There is a Velcro chinstrap that is used as a method of suspension. The chinstrap is fastened securely through the Dacron loops at the cut out section for the infants' ears. The chinstrap holds the helmet in place eliminating the risk of slippage. There are air holes drilled into the helmet for ventilation.
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