510(k) Report

Devices descending from K903434

24 later devices reach Select Neuromuscular Stimulators through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K974514External Functional Neuromuscular StimulatorNeuromotion, Inc.199823—
+2K053468NESS L300Ness-Neuromuscular Electrical Stimulation Systems200617—
+2K052329Walkaide System, Models 20-0100, 20-0310, 20-1000Innovative Neurotronics, Inc.2005161
+2K050991The Odfs Dropped Foot StimulatorDepartment of Medical Physics and Biomedical Eng.200520—
+3K171396ODFS Pace XLOdstock Medical, Ltd.20180—
+3K123972Walkaide SystemInnovative Neurotronics, Inc.201314—
+3K122784Ness L300 System Kit, Lef Model LG3-5100; Ness L300 System Kit, Right Model LG3-5000…Bioness, Inc.201210—
+3K102115Odfs PaceOdstock Medical, Ltd.201116—
+3K080219Modification to:Ness L300Ness-Neuromuscular Electrical Stimulation Systems200816—
+4K162718Foot Drop System (Model XFT-2001D)Shenzhen Xft Medical Limited20171—
+4K162407L300 Go SystemBioness, Inc.20179—
+4K141812Mygait Stimulation SystemOtto Bock Healthcare Products GmbH20151—
+4K140886Walkaide SystemInnovative Neurotronics, Inc.201410—
+4K103343L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left)Bioness, Inc.201115—
+5K202110MStim Drop Model: LGT-233Guangzhou Longest Science & Technology Co., Ltd.20210—
+5K193276Nerve and Muscle StimulatorShenzhen Xft Medical Limited20200—
+5K173682L300 Go SystemBioness, Inc.20187—
+6K230997EvoWalk 1.0 SystemEvolution Devices, Inc.20230—
+6K190285L300 Go SystemBioness, Inc.20195—
+7K213622Cionic Neural Sleeve NS-100Cionic20222—
+7K200262L100 Go SystemBioness, Inc.20200—
+7K191587L360 Thigh SystemBioness, Inc.20190—
+8K221823Cionic Neural Sleeve NS-100Cionic20221—
+9K243828Cionic Neural Sleeve (NS-200)Cionic, Inc.20250—