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Welcome at Eforto compliance
Eforto has been registered as a Class II Medical Device with the U.S. FDA since March 2025.
For the European market, we are currently in the registration process with the Notified Body to obtain certification as a Class IIa medical device under the MDR. We expect this registration to be completed by the end of 2026.
At present, in the EU, Eforto can be used in two contexts:
As a health device for use in healthy individuals to measure muscle strength and muscle fatigability as fitness parameters.
As an investigational medical device within clinical studies.
We would be happy to further discuss your use case and explore how we can best support you. Please contact us via: connect@eforto.com