510(k) K191435

IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 by Nalu Medical, Inc. — Product Code GZF

K191435 is an FDA 510(k) premarket notification submitted by Nalu Medical, Inc. for the device "IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4". The FDA issued a decision of Substantially Equivalent on September 6, 2019. The device falls under product code GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5870.