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 in 2028.

At present, in the EU, Eforto can only be used in two contexts:

1. The Eforto R1, as a wellness device for use in healthy individuals to measure muscle strength and muscle fatigability as fitness parameters.

2. The Eforto M1, 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

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