FDA.reportPublic FDA data

L300 Go System

Primary DI
00810188050595
Brand
L300 Go System
Company
Bioness Medical, Inc.
Model
LG4-SW01
Device description
Clinician Programmer Software for L300 Go System
Published
2025-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZIStimulator, Neuromuscular, External Functional
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZIStimulator, Neuromuscular, External FunctionalNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190285000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190285000L300 Go SystemBioness, Inc.2019-03-14GZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815962020061PreviousGS10
00810188050595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815962020061008159620200618159620200610815962020061
00810188050595008101880505958101880505950810188050595

GMDN Terms#

Term, Definition table
TermDefinition
Gait-enhancement electrical stimulation system, externalAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)211-9136info@bionessmedical.com

Regulatory Flags#

DUNS number
119378513
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810188050014Vector Gait and Safety SystemVEC-10002025-07-18
00810188050021Bioness Integrated System (BITS) Bedside ConfigurationBIT-21242025-07-18
00810188050045Bioness Integrated Therapy System, BITS 3.0, BITS BalanceBIT-31552025-07-18
00810188050052L360 Thigh SystemL4T-60002025-07-18
00810188050083L300 Go SystemLG4-51002025-07-18
00810188050120L300 Go SystemL4P-50012025-07-18
00810188050175L100 Go SystemLG1-5X002025-07-18
00810188050274L300 Go SystemLG4-10002025-07-18
00810188050441H200 Wireless SystemH2W-5D002025-07-18
00810188050557Vector BaseVEC-30002025-07-18
00810188050038Bioness Integrated System (BITS) Mobile ConfigurationBIT-22242025-07-17
00810188050069L360 Thigh SystemL4T-60012025-07-17
00810188050076L300 Go SystemLG4-50002025-07-17
00810188050090L300 Go SystemLG4-5U002025-07-17
00810188050106L300 Go SystemLG4-5V002025-07-17
00810188050113L300 Go SystemL4P-51002025-07-17
00810188050137L300 Go SystemL4T-50002025-07-17
00810188050144L300 Go SystemL4T-50012025-07-17
00810188050168L100 Go SystemLG1-5Y002025-07-17
00810188050236L300 Go SystemL4P-5D002025-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
08809308380041Talent-pro Electromagnetic StimulatorREMED Co.,Ltd.IPF2026-05-13
07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
00714905117649Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00714905710024Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00810140062680RENPHOJoicom CorporationIPF2025-10-20
00810140062697RENPHOJoicom CorporationIPF2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.IPF2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.IPF2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.IPF2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.IPF2025-09-11
00810113683379DualPulse CompactManamed, Inc.IPF2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.IPF2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.IPF2025-08-21
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.IPF2025-07-21
00810188050052L360 Thigh SystemBioness Medical, Inc.IPF2025-07-18
00810188050083L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050120L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050175L100 Go SystemBioness Medical, Inc.IPF2025-07-18
00810188050274L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050069L360 Thigh SystemBioness Medical, Inc.GZI2025-07-17
00810188050076L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050090L300 Go SystemBioness Medical, Inc.GZI2025-07-17