L300 Go Clinician Programmer Software

GUDID 00815962020061

Clinician Programmer Software for L300 Go system

BIONESS INC.

Gait-enhancement electrical stimulation system, external Gait-enhancement electrical stimulation system, external Gait-enhancement electrical stimulation system, external
Primary Device ID00815962020061
NIH Device Record Keyd3ae9623-a791-4acd-a799-fc0a854fc14c
Commercial Distribution StatusIn Commercial Distribution
Brand NameL300 Go Clinician Programmer Software
Version Model NumberLG4-SW01
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100815962020061 [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 Date2018-01-19

Devices Manufactured by BIONESS INC.

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00815962020627 - Bioness Integrated Therapy System, BITS 3.0, BITS Balance2020-08-18 BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit
00815962020634 - BITS Motion Sensor2020-08-18 Bioness Integrated Therapy System Version 3.0 Motion Sensor
00815962020337 - L100 Go System2020-04-30 L100 Go System, Right
00815962020344 - L100 Go System2020-04-30 L100 Go System, Left
07290110482008 - NESS H200® Wireless Hand Rehabilitation System2019-11-08 H200 Wireless US System kit, Right Medium
07290110482015 - NESS H200® Wireless Hand Rehabilitation System2019-11-08 H200 Wireless US System kit, Left Medium

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