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HELMETS
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Our “rubber pegs” are made out of a polymer called G2705 GU made by Kraton Polymers. This part is biocompatible and has been tested on mice and rabbits. It also meets USP VI and has passed tests for biological reactivity for in vivo applications.
We have chosen this part because this is really the only part that interfaces with the patient's head. The exposure for such material to the scalp is less than 24 hours so this adheres to the ISO10993 protocol which is “Limited” and a surface device so it is labeled as a non-significant risk (SNR) device.
The other materials are made out of ABS plastic + PC composite and are inert materials and do not interface with the human scalp. This makes it well suited for typical medical device housings and exhibits stability and is mechanically robust.
Updated on 20 Dec 2023