FDA.reportPublic FDA data

Gait-enhancement electrical stimulation system, external

Definition
An assembly of devices that applies electrical stimuli to the lower extremity nerves (e.g., peroneal or femoral) or muscles (e.g., those that cause ankle dorsiflexion), to cause the muscles in the leg to contract, thus improving the gait in a patient suffering from partial paralysis of the lower extremities or other neuromuscular disorders. It typically includes electrodes and an external pulse generator (EPG), and may be incorporated into an external prosthesis.
GUDID devices
56
Last updated
2026-06-13 06:05:06

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
G345SL2000CIONICCionic, Inc.NS-2002026-06-04
G345NS1000CIONICCionic, Inc.NS-1002022-12-15
00860011699309EvoWalkEvolution Devices, Inc.1.02025-08-06
00810188050052L360 Thigh SystemBioness Medical, Inc.L4T-60002025-07-18
00810188050083L300 Go SystemBioness Medical, Inc.LG4-51002025-07-18
00810188050120L300 Go SystemBioness Medical, Inc.L4P-50012025-07-18
00810188050175L100 Go SystemBioness Medical, Inc.LG1-5X002025-07-18
00810188050069L360 Thigh SystemBioness Medical, Inc.L4T-60012025-07-17
00810188050076L300 Go SystemBioness Medical, Inc.LG4-50002025-07-17
00810188050090L300 Go SystemBioness Medical, Inc.LG4-5U002025-07-17
00810188050106L300 Go SystemBioness Medical, Inc.LG4-5V002025-07-17
00810188050113L300 Go SystemBioness Medical, Inc.L4P-51002025-07-17
00810188050137L300 Go SystemBioness Medical, Inc.L4T-50002025-07-17
00810188050144L300 Go SystemBioness Medical, Inc.L4T-50012025-07-17
00810188050168L100 Go SystemBioness Medical, Inc.LG1-5Y002025-07-17
00810188050595L300 Go SystemBioness Medical, Inc.LG4-SW012025-07-17
G345DC1000CIONICCionic, Inc.DC-1002024-01-26
G345SL1000CIONICCionic, Inc.SL-1002024-01-26
G345620000030CIONICCionic, Inc.102022-12-01
G345620000040CIONICCionic, Inc.102022-12-01
04260397620410RehaStim2HASOMED GmbHFES010922020-11-22
04260397620427RehaStim 2 for HocomaHASOMED GmbHFES010502020-11-22
00815962020337L100 Go SystemBIONESS INC.LG1-5Y002020-04-22
00815962020344L100 Go SystemBIONESS INC.LG1-5X002020-04-22
00815962020382L360 Thigh SystemBIONESS INC.L4T-60012019-09-30
00815962020399L360 Thigh SystemBIONESS INC.L4T-60002019-09-30
04260397620342RehaStim 2HASOMED GmbHFES010902017-04-05
04260397620670RehaStim 2HASOMED GmbHFES010502018-06-05
05060195470441ODFS Pace XLODSTOCK MEDICAL LIMITED1.12018-08-22
07290110483005NESS L300-Plus SystemBIONESS INC.L3P-50012017-02-02
07290110483012NESS L300-Plus SystemBIONESS INC.L3P-50002017-02-02
07290110483029NESS L300-Plus SystemBIONESS INC.L3P-51012017-02-02
07290110483036NESS L300-Plus SystemBIONESS INC.L3P-51002017-02-02
07290110483043NESS L300-Plus SystemBIONESS INC.L3P-41002017-02-02
07290110483050NESS L300 Foot Drop SystemBIONESS INC.LG3-51002017-02-02
07290110483067NESS L300 Foot Drop SystemBIONESS INC.LG3-50002017-02-02
07290110483074NESS L300 Foot Drop SystemBIONESS INC.LG3-40002017-02-02
07290110483081NESS L300 Foot Drop SystemBIONESS INC.LG3-5V002017-02-02
07290110483098NESS L300 Foot Drop SystemBIONESS INC.LG3-5U002017-02-02
00858184006000WalkAide UnitINNOVATIVE NEUROTRONICS, INC.20-01002016-08-16
00858184006017WalkAide KitINNOVATIVE NEUROTRONICS, INC.20-10002016-08-16
00858184006031WalkAide Kit for JapanINNOVATIVE NEUROTRONICS, INC.21-10002016-08-16
00858184006048WalkAide Kit for Demo UseINNOVATIVE NEUROTRONICS, INC.20-10022016-08-16
00858184006055WalkLink UnitINNOVATIVE NEUROTRONICS, INC.20-03102016-08-16
00858184006062WalkLink System ((Clinician Kit)INNOVATIVE NEUROTRONICS, INC.20-03002016-08-16
00858184006130WalkAnalyst Software KitINNOVATIVE NEUROTRONICS, INC.20-06032016-08-16
00815962020061L300 Go Clinician Programmer SoftwareBIONESS INC.LG4-SW012018-01-19
00815962020115L300 Go Clinician KitBIONESS INC.LG4-40002017-02-14
00815962020139L300 Go System, Left Lower LegBIONESS INC.LG4-51002017-02-14
00815962020146L300 Go System, Left Small Lower LegBIONESS INC.LG4-5V002017-02-14
00815962020153L300 Go System, Left Thigh PlusBIONESS INC.L4P-50012017-02-14
00815962020160L300 Go System, Left Thigh Stand-AloneBIONESS INC.L4T-50012017-02-14
00815962020177L300 Go System, Right Lower LegBIONESS INC.LG4-50002017-02-14
00815962020184L300 Go System, Right Small Lower LegBIONESS INC.LG4-5U002017-02-14
00815962020191L300 Go System, Right Thigh PlusBIONESS INC.L4P-51002017-02-14
00815962020207L300 Go SystemBIONESS INC.L4T-50002017-02-14