NeuroEDUCATOR

GUDID 00864267000421

CONTROL BIONICS INCORPORATED

Biofeedback system

• Primary Device ID: 00864267000421
• NIH Device Record Key: 4640e2c9-a4ca-4b90-9d98-b60eb86ae149
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroEDUCATOR
• Version Model Number: PL-21-1000
• Company DUNS: 964598481
• Company Name: CONTROL BIONICS INCORPORATED
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864267000421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854277

FDA Product Code

• HCC: Device, Biofeedback

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-06

Devices Manufactured by CONTROL BIONICS INCORPORATED

• 00864267000421 - NeuroEDUCATOR: 2018-07-06
• 00864267000421 - NeuroEDUCATOR: 2018-07-06
• 00864267000407 - NeuroNode: 2018-04-06
• 00864267000414 - NeuroSwitch: 2018-04-06