Question for and/or Shane

[Guest guest]

My sons received their helmets from the rehab. facility at Lucile Packard

Children's Hospital at Stanford Univ. Knowing what I learned from your emails, I

asked the doctor making the casts whether the helmets were FDA approved. He

responded by saying that FDA approval is given to the facility, not to a

particular device, and yes, their rehab. facility is FDA approved. Is this

right? From your conversations on this subject, I thought approval had to be

given to the particular device.

Thanks for any info. you can give me,

Semke