510(k) K100399

4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A by Well-Life Healthcare Limited — Product Code GZJ

K100399 is an FDA 510(k) premarket notification submitted by Well-Life Healthcare Limited for the device "4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A". The FDA issued a decision of Substantially Equivalent on June 25, 2010. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Well-Life Healthcare Limited has at least 10 other 510(k) clearances on record.