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510(k) Data Aggregation
K Number
K013700Device Name
ORTHOSIS HELMET MOLDING
Manufacturer
PRECISION PROSTHETICS & ORTHOTICS, INC.
Date Cleared
2002-02-05
(89 days)
Product Code
MVA
Regulation Number
882.5970Why did this record match?
Applicant Name (Manufacturer) :
**PRECISION PROSTHETICS **& ORTHOTICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Precision Prosthetics and Orthotics, Inc. orthotic molding 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 non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
Device Description
The Precision Prosthetic and Orthotics, Inc. orthotic molding helmet is a cranial orthosis for the treatment of deformational plagiocephaly. It is a foam-lined, lightweight, bivalve rigid plastic helmet with the anterior section overlapping the posterior section. Each helmet is assembled individually, with some areas that fit snugly to the child's head, and with other open areas. As the child's brain grows, the skull is slowly reshaped and rounded by growing into the open areas.
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