L360 Thigh System

GUDID 00810188050052

L360 Thigh System Kit, Right

Bioness Medical, Inc.

Gait-enhancement electrical stimulation system, external
Primary Device ID00810188050052
NIH Device Record Key3b12af31-4bb4-4c1c-80bc-df542d6ab384
Commercial Distribution StatusIn Commercial Distribution
Brand NameL360 Thigh System
Version Model NumberL4T-6000
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 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@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
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
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
GS100810188050052 [Primary]
GS100815962020399 [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 Date2025-07-28
Device Publish Date2025-07-18

On-Brand Devices [L360 Thigh System]

00810188050069L360 Thigh System Kit, Left
00810188050052L360 Thigh System Kit, Right

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