510(k) K052289

DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE by Biowave Corporation — Product Code LIH

K052289 is an FDA 510(k) premarket notification submitted by Biowave Corporation for the device "DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE". The FDA issued a decision of Substantially Equivalent on December 13, 2005. The device falls under product code LIH (Interferential Current Therapy), a Class II device regulated under 21 CFR 882.5890. Biowave Corporation has at least 7 other 510(k) clearances on record.