cranial orthosis (for plagiocephaly)
Eileen Levis, Administr.
Description
Collection
Title:
cranial orthosis (for plagiocephaly)
Creator:
Eileen Levis, Administr.
Text:
Dear Members:
As you know the FDA has classified the above device as a Class II
device
(with special controls). This means that we as providers need to submit to
the FDA for premarket notification (510k) if we will be marketing this
device. I am interested in
locating a practice or supplier that is pursuing this currently (other than
Doc Band)
and also whether anyone will be wholesaling this device to the general
orthotic community.
Eileen Levis
Administrator
HARRY J. LAWALL & SON
As you know the FDA has classified the above device as a Class II
device
(with special controls). This means that we as providers need to submit to
the FDA for premarket notification (510k) if we will be marketing this
device. I am interested in
locating a practice or supplier that is pursuing this currently (other than
Doc Band)
and also whether anyone will be wholesaling this device to the general
orthotic community.
Eileen Levis
Administrator
HARRY J. LAWALL & SON
Citation
Eileen Levis, Administr., “cranial orthosis (for plagiocephaly),” Digital Resource Foundation for Orthotics and Prosthetics, accessed November 5, 2024, https://library.drfop.org/items/show/214197.
