510(k) Report

Devices descending from K061166

12 later devices reach Deepwave Percutaneous Neuromodulation Pain Therapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211801SPRINT PNS SystemSpr Therapeutics, Inc.20211—
+1K161154Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…Spr Therapeutics, LLC20169—
+1K072123Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation200811—
+2K243782StimTrial Neuromodulation SystemBioventus, LLC20250—
+2K223306SPRINT Peripheral Nerve Stimulation (PNS) SystemSpr Therapeutics, Inc.20230—
+2K212859First ReliefDyansys, Inc.20210—
+2K170902Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit…Spr Therapeutics, LLC20177—
+2K090866Neurocalm Model 1 and 2Neuromed Devices, Inc.20090—
+3K181422SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation…Spr Therapeutics, Inc.20186—
+4K202660SPRINT PNS SystemSpr Therapeutics, Inc.20215—
+5K213188Primary ReliefDyansys, Inc.20221—
+6K221425Primary ReliefDyansys, Inc.20220—