L300 Go System, Left Thigh Stand-Alone

GUDID 00815962020160

L300 Go system with Left Thigh cuff only

BIONESS INC.

Gait-enhancement electrical stimulation system, external

• Primary Device ID: 00815962020160
• NIH Device Record Key: b5ada65c-b189-4c70-935e-3041ee59587a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L300 Go System, Left Thigh Stand-Alone
• Version Model Number: L4T-5001
• 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	00815962020160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162407

FDA Product Code

• GZI: STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL

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

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