510(k) K202979

MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra by Lode B.V. — Product Code ISD

K202979 is an FDA 510(k) premarket notification submitted by Lode B.V. for the device "MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra". The FDA issued a decision of Substantially Equivalent on December 21, 2020. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360. Lode B.V. has at least 2 other 510(k) clearances on record.