510(k) K171366

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit by Stimwave Technologies Inc., Dba Stimq, LLC — Product Code GZF

K171366 is an FDA 510(k) premarket notification submitted by Stimwave Technologies Inc., Dba Stimq, LLC for the device "Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit". The FDA issued a decision of Substantially Equivalent on August 4, 2017. The device falls under product code GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5870.