510(k) K091940

MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION by Tonica Elektronik A/S — Product Code GWF

K091940 is an FDA 510(k) premarket notification submitted by Tonica Elektronik A/S for the device "MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION". The FDA issued a decision of Substantially Equivalent on March 26, 2010. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Tonica Elektronik A/S has at least 10 other 510(k) clearances on record.