L300 Go Clinician Kit

GUDID 00815962020115

L300 Go Accessories

BIONESS INC.

Gait-enhancement electrical stimulation system, external Gait-enhancement electrical stimulation system, external Gait-enhancement electrical stimulation system, external
Primary Device ID00815962020115
NIH Device Record Keya6dd666f-afc1-4ba8-b344-0fd74621c509
Commercial Distribution StatusIn Commercial Distribution
Brand NameL300 Go Clinician Kit
Version Model NumberLG4-4000
Company DUNS182287727
Company NameBIONESS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
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
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100815962020115 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2017-02-14

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