510(k) Report

Devices descending from K170141

19 later devices reach Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183047Nalu Neurostimulation SystemBoston Scientific Neuromodulation201961
+1K180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitStimwave Technologies Incorporated20181—
+1K171366Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory…Stimwave Technologies Inc., Dba Stimq, LLC201796
+2K233162Freedom Peripheral Nerve Stimulator (PNS) SystemCuronix20240—
+2K202274Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit…Boston Scientific Neuromodulation20200—
+2K200848Stimulator, Stimulator Kit, External Transmitter, External Transmitter KitMicron Medical Corporation20200—
+2K201618Nalu Neurostimulation SCS systemBoston Scientific Neuromodulation20203—
+2K190960Nalu Lead Blank (50cm)Boston Scientific Neuromodulation20190—
+2K183579Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation…Boston Scientific Neuromodulation201961
+2K182720Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated20190—
+3K243782StimTrial Neuromodulation SystemBioventus, LLC20250—
+3K243678TalisMann Neuromodulation SystemBioventus, LLC20250—
+3K232415Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation20240—
+3K202781Neuspera Neurostimulation System (NNS)Neuspera Medical, Inc.20211—
+3K203547Nalu Neurostimulation SystemBoston Scientific Neuromodulation20212—
+3K191435IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4…Nalu Medical, Inc.20190—
+4K221303Neuspera Nuity SystemNeuspera Medical, Inc.20230—
+4K221376Nalu Neurostimulation SystemBoston Scientific Neuromodulation20221—
+5K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System…Boston Scientific Neuromodulation202401