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510(k) Data Aggregation
K Number
K012804Device Name
PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS
Manufacturer
SCOTT E ALLEN CP
Date Cleared
2002-01-17
(149 days)
Product Code
MVA
Regulation Number
882.5970Why did this record match?
Applicant Name (Manufacturer) :
SCOTT E ALLEN CP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use would include infants from three to eighteen months of age to be treated for Plagiocephalic, Brachycephalic, or scaphocephalic shaped heads by a medical physician. The purpose of the P.A.P. Orthosis is to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape. This device is to be prescribed by a physician in writing indicating the need for cranial positional molding due to the above diagnoses. The device is indicated to treat moderate to severe nonsynostotic positional plagiocephaly.
Device Description
It is a proprietary transparent ionomer based thermoplastic molded orthosis extended for medial purposes to apply pressure to the prominent regions of an infants cranium to improve cranial symmetry and to shape. This orthosis is used to treat infants from three to eighteen months of age with a diagnosis of moderate to severe non-synastolic positional Plagiocephaly.
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