510(k) Report

Devices descending from K103343

15 later devices reach L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162407L300 Go SystemBioness, Inc.20179—
+1K141812Mygait Stimulation SystemOtto Bock Healthcare Products GmbH20151—
+1K123972Walkaide SystemInnovative Neurotronics, Inc.201314—
+2K202110MStim Drop Model: LGT-233Guangzhou Longest Science & Technology Co., Ltd.20210—
+2K173682L300 Go SystemBioness, Inc.20187—
+2K162718Foot Drop System (Model XFT-2001D)Shenzhen Xft Medical Limited20171—
+2K140886Walkaide SystemInnovative Neurotronics, Inc.201410—
+3K230997EvoWalk 1.0 SystemEvolution Devices, Inc.20230—
+3K193276Nerve and Muscle StimulatorShenzhen Xft Medical Limited20200—
+3K190285L300 Go SystemBioness, Inc.20195—
+4K213622Cionic Neural Sleeve NS-100Cionic20222—
+4K200262L100 Go SystemBioness, Inc.20200—
+4K191587L360 Thigh SystemBioness, Inc.20190—
+5K221823Cionic Neural Sleeve NS-100Cionic20221—
+6K243828Cionic Neural Sleeve (NS-200)Cionic, Inc.20250—