L300 Go System, Left Lower Leg

GUDID 00815962020139

L300 Go system with Lower Left cuff

BIONESS INC.

Gait-enhancement electrical stimulation system, external Gait-enhancement electrical stimulation system, external Gait-enhancement electrical stimulation system, external

• Primary Device ID: 00815962020139
• NIH Device Record Key: 196fc68b-00d7-409a-aa42-896d4f47a56e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L300 Go System, Left Lower Leg
• Version Model Number: LG4-5100
• Company DUNS: 182287727
• Company Name: BIONESS 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: true
• 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@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815962020139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162407

FDA Product Code

• IPF: Stimulator, muscle, powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-02-14

Devices Manufactured by BIONESS INC.

• 00815962021464 - StimRouter User Kit: 2022-10-25 External Electrical Field Conductor
• 00815962020610 - Bioness Integrated Therapy System, BITS 3.0, BITS Balance: 2020-08-18 Bioness Integrated Therapy System Version 3.0, Hardware It - 55" Display, BITS Software Kit, BITS PC Kit, BITS Balance Accessory
• 00815962020627 - Bioness Integrated Therapy System, BITS 3.0, BITS Balance: 2020-08-18 BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit
• 00815962020634 - BITS Motion Sensor: 2020-08-18 Bioness Integrated Therapy System Version 3.0 Motion Sensor
• 00815962020337 - L100 Go System: 2020-04-30 L100 Go System, Right
• 00815962020344 - L100 Go System: 2020-04-30 L100 Go System, Left
• 07290110482008 - NESS H200® Wireless Hand Rehabilitation System: 2019-11-08 H200 Wireless US System kit, Right Medium
• 07290110482015 - NESS H200® Wireless Hand Rehabilitation System: 2019-11-08 H200 Wireless US System kit, Left Medium