L300 Go System

GUDID 00810188050328

Small Quick Fit Electrodes - A

Bioness Medical, Inc.

Transcutaneous electrical stimulation electrode, reusable
Primary Device ID00810188050328
NIH Device Record Keyb7ba947a-a860-4ee3-b453-9b9afc98b6e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameL300 Go System
Version Model NumberLG3-6800
Company DUNS119378513
Company NameBioness Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)211-9136
Emailinfo@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com
Phone+1(800)211-9136
Emailinfo@bionessmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810188050328 [Primary]
GS100815962020498 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZIStimulator, Neuromuscular, External Functional

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-25
Device Publish Date2025-07-17

On-Brand Devices [L300 Go System]

00810188050595Clinician Programmer Software for L300 Go System
00810188050342Hydrogel Electrode Set
00810188050335Small Quick Fit Electrodes - B
00810188050328Small Quick Fit Electrodes - A
00810188050311Small Hydrogel Electrodes, 36mm
00810188050304Small Round Cloth Electrodes, 36mm
00810188050298Round Cloth Electrodes, 45mm
00810188050281Quick Fit Electrode, Left
00810188050267Steering Cloth Electrode, Left
00810188050250Steering Cloth Electrode, Right
00810188050243Thigh Cloth Electrode Set, Offset
00810188050236Thigh Cloth Electrode Set, Centered
00810188050144L300 Go System, Left Thigh Stand-Alone
00810188050137L300 Go System, Right Thigh Stand-Alone
00810188050113L300 Go System, Right Thigh Plus
00810188050106L300 Go System, Left Small Lower
00810188050090L300 Go System, Right Small Lower
00810188050076L300 Go System, Right Lower

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