L100 Go System

GUDID 00815962020344

L100 Go System, Left

BIONESS INC.

Gait-enhancement electrical stimulation system, external
Primary Device ID00815962020344
NIH Device Record Keyd2e18f96-4c3f-472b-91d8-669525da904a
Commercial Distribution StatusIn Commercial Distribution
Brand NameL100 Go System
Version Model NumberLG1-5X00
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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@bioness.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100815962020344 [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 Date2020-04-30
Device Publish Date2020-04-22

On-Brand Devices [L100 Go System]

00815962020344L100 Go System, Left
00815962020337L100 Go System, Right

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