Device Safety

 

The WAVE is made from passivated 304L medical grade stainless steel and certified biocompatible plastics.  Wave has also passed biocompatibity testing (Cytotoxicity, Sensitizatiion and Vaginal irritation) conducted by NAMSA, an independent testing lab.

The device is powered by a conventional and disposable, 1.5 Volt LR44 alkaline watch battery and presents no electrical shock hazard to the user. 

During the two published studies that were conducted on the Wave’s predecessor devices,  there were no adverse events attributable to the devices.  In our internal testing, we have never encountered an adverse event attributable to the WAVE.  An FMEA analysis has shown the WAVE to be a low risk device.