FDA.reportPublic FDA data

L300 Go System

Primary DI
00810188050304
Brand
L300 Go System
Company
Bioness Medical, Inc.
Model
LG3-6600
Device description
Small Round Cloth Electrodes, 36mm
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
00815962020474PreviousGS10
00810188050304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815962020474008159620204748159620204740815962020474
00810188050304008101880503048101880503040810188050304

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrode, reusableAn electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a reusable device.

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
Manufacturing date on label
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