L300 Go System

GUDID 00810188050090

L300 Go System, Right Small Lower

Bioness Medical, Inc.

Gait-enhancement electrical stimulation system, external

• Primary Device ID: 00810188050090
• NIH Device Record Key: 9c2354f0-dca7-4585-980e-f9efbe7f573c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L300 Go System
• Version Model Number: LG4-5U00
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810188050090 [Primary]
GS1	00815962020184 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190285

FDA Product Code

• IPF: Stimulator, Muscle, Powered

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: 2025-07-25
• Device Publish Date: 2025-07-17

On-Brand Devices [L300 Go System]

• 00810188050595: Clinician Programmer Software for L300 Go System
• 00810188050342: Hydrogel Electrode Set
• 00810188050335: Small Quick Fit Electrodes - B
• 00810188050328: Small Quick Fit Electrodes - A
• 00810188050311: Small Hydrogel Electrodes, 36mm
• 00810188050304: Small Round Cloth Electrodes, 36mm
• 00810188050298: Round Cloth Electrodes, 45mm
• 00810188050281: Quick Fit Electrode, Left
• 00810188050267: Steering Cloth Electrode, Left
• 00810188050250: Steering Cloth Electrode, Right
• 00810188050243: Thigh Cloth Electrode Set, Offset
• 00810188050236: Thigh Cloth Electrode Set, Centered
• 00810188050144: L300 Go System, Left Thigh Stand-Alone
• 00810188050137: L300 Go System, Right Thigh Stand-Alone
• 00810188050113: L300 Go System, Right Thigh Plus
• 00810188050106: L300 Go System, Left Small Lower
• 00810188050090: L300 Go System, Right Small Lower
• 00810188050076: L300 Go System, Right Lower