510(k) K970491

DUPEL II BUFFERED IONTOPHORESIS ELECTRODES by Empi — Product Code EGJ

K970491 is an FDA 510(k) premarket notification submitted by Empi for the device "DUPEL II BUFFERED IONTOPHORESIS ELECTRODES". The FDA issued a decision of Substantially Equivalent on May 30, 1997. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525. Empi has at least 10 other 510(k) clearances on record.