L360 Thigh System

GUDID 00810188050069

L360 Thigh System Kit, Left

Bioness Medical, Inc.

Gait-enhancement electrical stimulation system, external

• Primary Device ID: 00810188050069
• NIH Device Record Key: a9fc2c1e-cf0c-4de6-8fa5-2e0f5889b815
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L360 Thigh System
• Version Model Number: L4T-6001
• 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	00810188050069 [Primary]
GS1	00815962020382 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191587

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

Devices Manufactured by Bioness Medical, Inc.

• 00810188050038 - Bioness Integrated System (BITS) Mobile Configuration: 2025-07-25 Bioness Integrated Therapy System, Version 2.0, Mobile Configuration, 24" Display with Software
• 00810188050069 - L360 Thigh System: 2025-07-25L360 Thigh System Kit, Left
• 00810188050069 - L360 Thigh System: 2025-07-25 L360 Thigh System Kit, Left
• 00810188050076 - L300 Go System: 2025-07-25 L300 Go System, Right Lower
• 00810188050090 - L300 Go System: 2025-07-25 L300 Go System, Right Small Lower
• 00810188050106 - L300 Go System: 2025-07-25 L300 Go System, Left Small Lower
• 00810188050113 - L300 Go System: 2025-07-25 L300 Go System, Right Thigh Plus
• 00810188050137 - L300 Go System: 2025-07-25 L300 Go System, Right Thigh Stand-Alone
• 00810188050144 - L300 Go System: 2025-07-25 L300 Go System, Left Thigh Stand-Alone