510(k) K180981

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit by Stimwave Technologies Incorporated — Product Code GZB

K180981 is an FDA 510(k) premarket notification submitted by Stimwave Technologies Incorporated for the device "Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit". The FDA issued a decision of Substantially Equivalent on September 19, 2018. The device falls under product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5880. Stimwave Technologies Incorporated has at least 7 other 510(k) clearances on record.