510(k) K162161

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit by Stimwave Technologies Incorporated — Product Code GZB

K162161 is an FDA 510(k) premarket notification submitted by Stimwave Technologies Incorporated for the device "Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit". The FDA issued a decision of Substantially Equivalent on December 16, 2016. 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.