FDA.reportPublic FDA data

L300 Go System

Primary DI
00815962020405
Brand
L300 Go System
Company
BIONESS INC.
Model
L4P-5D00
Device description
Thigh Cloth Electrode Set, Centered
Published
2019-06-14
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815962020405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815962020405008159620204058159620204050815962020405

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile 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, 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 single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
182287727
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815962021464StimRouter User KitST2-50502022-10-17
00815962020528H200 Wireless SystemH2W-53002019-08-08
00815962020535H200 Wireless SystemH2W-52002019-08-08
00815962020542H200 Wireless SystemH2W-55002019-08-08
00815962020559H200 Wireless SystemH2W-54002019-08-08
00815962020566H200 Wireless SystemH2W-40002019-08-08
00815962020573H200 Wireless SystemH2W-41002019-08-08
00815962020580H200 Wireless SystemH2W-51002019-08-08
00815962020597H200 Wireless SystemH2W-50002019-08-08
00815962020603H200 Wireless SystemH2W-47002019-08-08
07290110482008NESS H200® Wireless Hand Rehabilitation SystemH2W-5300501-00037-012017-02-02
07290110482015NESS H200® Wireless Hand Rehabilitation SystemH2W-5200501-00038-012017-02-02
07290110482022NESS H200® Wireless Hand Rehabilitation SystemH2W-5500501-00041-012017-02-02
07290110482039NESS H200® Wireless Hand Rehabilitation SystemH2W-5400501-00042-012017-02-02
07290110482046NESS H200® Wireless Hand Rehabilitation SystemH2W-4000501-00094-012017-02-02
07290110482053NESS H200® Wireless Hand Rehabilitation SystemH2W-4100501-00095-012017-02-02
07290110482060NESS H200® Wireless Hand Rehabilitation SystemH2W-5100501-00120-012017-02-02
07290110482077NESS H200® Wireless Hand Rehabilitation SystemH2W-5000501-00121-012017-02-02
07290110482084NESS H200® Wireless Hand Rehabilitation SystemH2W-4700501-00176-012017-02-02
00815962020290H200 WirelessH2W-SW012018-02-08

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