We have considered the possible risks associated with using the geko® device. To ensure its safety we have designed and manufactured the geko® device in accordance with the International standard for managing the risks of medical devices, ISO 14971. Using this standard as a basis we have designed and manufactured the geko® devices to be intrinsically safe.
We have conducted extensive biological safety testing, to the International biocompatibility standard, ISO 10993, and we have data that shows that the hydrogel has tested negative for cytotoxicity, sensitisation and irritation, and can therefore be considered to be hypoallergenic. We have also conducted extensive electrical safety testing. The key International standards are ISO 60601-1, ISO 60601-1-2 and IEC 60601-2-10, the latter being the International standard for electrical safety for powered muscle stimulators.
All of the above data has been reviewed by our Notified Body (SGS United Kingdom Ltd) prior to giving us the CE Marking certification. SGS United Kingdom Ltd employs experts in biological and electrical safety testing to scrutinise the data that we have to demonstrate that the geko® devices are intrinsically safe and comply with appropriate International safety standards.
We have considered the possible risks associated with using the geko® device. To ensure its safety we have designed and manufactured the geko® device in accordance with the International standard for managing the risks of medical devices, ISO 14971. Using this standard as a basis we have designed and manufactured the geko® devices to be intrinsically safe.