L360 Thigh System

Basic Information

• Brand Name: L360 Thigh System
• Primary DI: 00815962020382
• Version / Model: L4T-6001
• Company Name: BIONESS INC.
• Labeler DUNS: 182287727
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-30
• Public Version: 1
• Public Version Date: 2019-10-08
• Public Version Status: New
• Public Device Record Key: 2746e292-8cb5-437a-ae43-696fe8701686

Device Description

L360 Thigh System Kit, Left

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IPF	Stimulator, muscle, powered	Physical Medicine	890.5850	2
GZI	STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL	Neurology	882.5810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35725	Gait-enhancement electrical stimulation system, external	An assembly of devices that applies electrical stimuli to the lower extremity nerves (e.g., peroneal or femoral) or muscles (e.g., those that cause ankle dorsiflexion), to cause the muscles in the leg to contract, thus improving the gait in a patient suffering from partial paralysis of the lower extremities or other neuromuscular disorders. It typically includes electrodes and an external pulse generator (EPG), and may be incorporated into an external prosthesis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815962020382	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K191587	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – 55 Degrees Celsius