EasyPrep Sensor Kit EK-901

GUDID B746EK9011

Neurowave Systems Inc.

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• Primary Device ID: B746EK9011
• NIH Device Record Key: 11b7cd2c-3625-42d3-81f8-4bb7d0f50ee2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyPrep Sensor Kit
• Version Model Number: EK-901
• Catalog Number: EK-901
• Company DUNS: 607075160
• Company Name: Neurowave Systems Inc.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B746EK9010 [Unit of Use]
HIBCC	B746EK9011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202621

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2023-11-10
• Device Publish Date: 2023-11-02

Devices Manufactured by Neurowave Systems Inc.

• B746EK9011 - EasyPrep Sensor Kit: 2023-11-10
• B746EK9011 - EasyPrep Sensor Kit: 2023-11-10
• B746NS90101 - NeuroSENSE: 2022-10-31