510(k) K071969

SEN-4100 ELECTRIC STIMULATOR by Nihon Kohden America, Inc. — Product Code GWF

K071969 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "SEN-4100 ELECTRIC STIMULATOR". The FDA issued a decision of Substantially Equivalent on October 6, 2008. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Nihon Kohden America, Inc. has at least 10 other 510(k) clearances on record.