510(k) K951951

FOCUS MODEL 795 UNIT by Empi — Product Code GZJ

K951951 is an FDA 510(k) premarket notification submitted by Empi for the device "FOCUS MODEL 795 UNIT". The FDA issued a decision of Substantially Equivalent on May 17, 1996. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Empi has at least 10 other 510(k) clearances on record.