Neuroglide A-00100

GUDID G067T1620200

Controller Unit for the Neuroglide Pain Relief and Recovery System.

Eva Medtec, Inc

Bed/chair electric massager

• Primary Device ID: G067T1620200
• NIH Device Record Key: 810e45d2-867c-4dc6-9689-f1842b5e88bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuroglide
• Version Model Number: T162020
• Catalog Number: A-00100
• Company DUNS: 100379368
• Company Name: Eva Medtec, 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: false
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G067T1620200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202693

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

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: 2021-06-03
• Device Publish Date: 2021-05-26

Devices Manufactured by Eva Medtec, Inc

• G067A001500 - Neuroglide Back Neck Pad: 2021-06-03 Back/Neck Therapy attachment used in conjunction with the Neuroglide Controller Unit
• G067T1620200 - Neuroglide: 2021-06-03Controller Unit for the Neuroglide Pain Relief and Recovery System.
• G067T1620200 - Neuroglide: 2021-06-03 Controller Unit for the Neuroglide Pain Relief and Recovery System.