L300 Go System

GUDID 00815962020504

Small Quick Fit Electrodes - B

BIONESS INC.

Transcutaneous electrical stimulation electrode
Primary Device ID00815962020504
NIH Device Record Key448170a7-4dfc-459c-852e-85056910bd2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameL300 Go System
Version Model NumberLG3-6900
Company DUNS182287727
Company NameBIONESS INC.
Device Count1
DM Exempttrue
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 Datefalse
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@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100815962020504 [Primary]

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 Date2019-06-24
Device Publish Date2019-06-14

On-Brand Devices [L300 Go System]

0081596202020710/17/2019
00815962020504Small Quick Fit Electrodes - B
00815962020498Small Quick Fit Electrodes - A
00815962020481Small Hydrogel Electrodes, 36mm
00815962020474Small Round Cloth Electrodes, 36mm
00815962020467Round Cloth Electrodes, 45mm
00815962020450Quick Fit Electrode, Left
00815962020443Quick Fit Electrode, Right
00815962020436Steering Cloth Electrode, Left
00815962020429Steering Cloth Electrode, Right
00815962020412Thigh Cloth Electrode Set, Offset
00815962020405Thigh Cloth Electrode Set, centered

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.