510(k) K232334

DEKA SIMON by El.En S.P.A. — Product Code IPF

K232334 is an FDA 510(k) premarket notification submitted by El.En S.P.A. for the device "DEKA SIMON". The FDA issued a decision of Substantially Equivalent on September 1, 2023. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. El.En S.P.A. has at least 10 other 510(k) clearances on record.