PTB Orthosis Standards
mhall
Description
Collection
Title:
PTB Orthosis Standards
Creator:
mhall
Date:
2/13/2001
Text:
Dear Members,
I am an undergraduate Biomedical Engineering student at the University of
Iowa, and plan to pursue a career in Orthotics and Prosthetics. Currently, my
Senior Design group is creating a modified version of the PTB orthosis, to
unload the problematic hindfoot. We are having difficulties finding
documentation or organizations which would regulate the materials and design
of this orthosis. Through research of the FDA web page we have concluded that
this orthosis is Class I and GMP Exempt, however there must be another
governing body who oversees the manufacture and design of off-the-shelf
orhtoses. We understand that custom made orthosis have little regulations.
If you have any information as to who sets the standards for the design of
orthoses (particularly PTBs) please email me at: <Email Address Redacted>
Thank you for your time and consideration.
Sincerely,
Michelle Hall
I am an undergraduate Biomedical Engineering student at the University of
Iowa, and plan to pursue a career in Orthotics and Prosthetics. Currently, my
Senior Design group is creating a modified version of the PTB orthosis, to
unload the problematic hindfoot. We are having difficulties finding
documentation or organizations which would regulate the materials and design
of this orthosis. Through research of the FDA web page we have concluded that
this orthosis is Class I and GMP Exempt, however there must be another
governing body who oversees the manufacture and design of off-the-shelf
orhtoses. We understand that custom made orthosis have little regulations.
If you have any information as to who sets the standards for the design of
orthoses (particularly PTBs) please email me at: <Email Address Redacted>
Thank you for your time and consideration.
Sincerely,
Michelle Hall
Citation
mhall, “PTB Orthosis Standards,” Digital Resource Foundation for Orthotics and Prosthetics, accessed November 2, 2024, https://library.drfop.org/items/show/215955.
