Re: Cranial Helmets
Description
Collection
Title:
Re: Cranial Helmets
Text:
Dear Wade:
Last week I responded to a posting regarding the cranial molding helmet
situation. In that post I failed to mention a recent and very positive
development in regard to this issue. OrthoAmerica recently received approval
from the FDA to manufacture cranial molding helmets. They are the first
manufacturer from within our field to complete the 510K process. They should
be congratulated for their success in dealing with the complexities of the
FDA approval process. As a result you do have another option at this time.
Best Regards:
Tom DiBello CO LO
Last week I responded to a posting regarding the cranial molding helmet
situation. In that post I failed to mention a recent and very positive
development in regard to this issue. OrthoAmerica recently received approval
from the FDA to manufacture cranial molding helmets. They are the first
manufacturer from within our field to complete the 510K process. They should
be congratulated for their success in dealing with the complexities of the
FDA approval process. As a result you do have another option at this time.
Best Regards:
Tom DiBello CO LO
Citation
“Re: Cranial Helmets,” Digital Resource Foundation for Orthotics and Prosthetics, accessed November 25, 2024, https://library.drfop.org/items/show/214533.
