a) The material we use is ABS plastic (acrylonitrile butadiene styrene), which is used for toys production, including Lego bricks.
b) It is not a medical device, and will not require FDA certification.
c) The overall profile dimensions of the enclosure are 1.27"x1.55". The 1.27" dimension completely prevents the product from fitting into the choke test tube. See
Regarding radiation concerns, there is a blog on our website: http://mondevices.com/2011/12/26/radiation-concern/
"Radiation of radio frequency (RF) devices are measured by Special absorption rate (SAR). It is defined as the power absorbed per mass of tissue and has units of watts per kilogram (W/kg). A general rule of thumb is, higher emission power would increase the SAR measurement.
Cellphones in US are limited to 1.6W/kg by regulation
Apple iPhone 4 : 1.17W/kg
Baby monitors range between 0.01-0.08W/kg
Bluetooth devices about 0.001W/kg
There is no public measurement data found for BLE yet, but given BLE has even lower power emission than Bluetooth, the SAR number should be very insignificant to be compared."
As you can see BLE device is 10-80 times less radiation than baby monitor.
It's also cordless, which eliminates all sorts of dangers with cords.