L100 Go System

GUDID 00810188050175

L100 Go System, Left

Bioness Medical, Inc.

Gait-enhancement electrical stimulation system, external

• Primary Device ID: 00810188050175
• NIH Device Record Key: 692c5edc-f8a7-42d0-9c6d-6aa53e740ac4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L100 Go System
• Version Model Number: LG1-5X00
• Company DUNS: 119378513
• Company Name: Bioness Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810188050175 [Primary]
GS1	00815962020344 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200262

FDA Product Code

• GZI: Stimulator, Neuromuscular, External Functional

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-28
• Device Publish Date: 2025-07-18

On-Brand Devices [L100 Go System]

• 00810188050168: L100 Go System, Right
• 00810188050175: L100 Go System, Left