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Important information: Medical devices are regulated by the competent regulatory body in each country. FemPulse devices are not yet approved or cleared for sale, including by the FDA in the U.S., and are not available other than potentially for controlled clinical investigation under NSR classification with IRB or EC approval. The content of this website is intended to be informational for medical professionals only, and makes no formal or substantiated claims about FemPulse's devices in development. All statements related to design intent require future verification of validity.