510(k) Report

Devices descending from K050991

20 later devices reach The Odfs Dropped Foot Stimulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171396ODFS Pace XLOdstock Medical, Ltd.20180—
+1K102115Odfs PaceOdstock Medical, Ltd.201116—
+1K053468NESS L300Ness-Neuromuscular Electrical Stimulation Systems200617—
+2K123972Walkaide SystemInnovative Neurotronics, Inc.201314—
+2K080219Modification to:Ness L300Ness-Neuromuscular Electrical Stimulation Systems200816—
+3K162718Foot Drop System (Model XFT-2001D)Shenzhen Xft Medical Limited20171—
+3K141812Mygait Stimulation SystemOtto Bock Healthcare Products GmbH20151—
+3K140886Walkaide SystemInnovative Neurotronics, Inc.201410—
+3K103343L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left)Bioness, Inc.201115—
+4K202110MStim Drop Model: LGT-233Guangzhou Longest Science & Technology Co., Ltd.20210—
+4K193276Nerve and Muscle StimulatorShenzhen Xft Medical Limited20200—
+4K162407L300 Go SystemBioness, Inc.20179—
+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—