L360 Thigh System

GUDID 00815962020399

L360 Thigh System Kit, Right

BIONESS INC.

Gait-enhancement electrical stimulation system, external

• Primary Device ID: 00815962020399
• NIH Device Record Key: ac740172-a410-418a-9dde-8ed330a032bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L360 Thigh System
• Version Model Number: L4T-6000
• Company DUNS: 182287727
• Company Name: BIONESS INC.
• Device Count: 1
• DM Exempt: true
• 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@bioness.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815962020399 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191587

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: 2019-10-08
• Device Publish Date: 2019-09-30

On-Brand Devices [L360 Thigh System]

• 00815962020399: L360 Thigh System Kit, Right
• 00815962020382: L360 Thigh System Kit, Left