BioPAK

GUDID 00860003499948

Bio-Research Associates, Inc.

Jaw physiology evaluation system Jaw physiology evaluation system Jaw physiology evaluation system Jaw physiology evaluation system Jaw physiology evaluation system Jaw physiology evaluation system Jaw physiology evaluation system Jaw physiology evaluation system Jaw physiology evaluation system Jaw physiology evaluation system Jaw physiology evaluation system Jaw physiology evaluation system Jaw physiology evaluation system Jaw physiology evaluation system Jaw physiology evaluation system Jaw physiology evaluation system Jaw physiology evaluation system Jaw physiology evaluation system

• Primary Device ID: 00860003499948
• NIH Device Record Key: 6546943f-8390-434e-a7bc-0a97c4d6a5d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioPAK
• Version Model Number: 9
• Company DUNS: 063501373
• Company Name: Bio-Research Associates, 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: false
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 4143577525
• Email: info@bioresearchinc.com
• Phone: 4143577525
• Email: info@bioresearchinc.com
• Phone: 4143577525
• Email: info@bioresearchinc.com
• Phone: 4143577525
• Email: info@bioresearchinc.com
• Phone: 4143577525
• Email: info@bioresearchinc.com
• Phone: 4143577525
• Email: info@bioresearchinc.com
• Phone: 4143577525
• Email: info@bioresearchinc.com
• Phone: 4143577525
• Email: info@bioresearchinc.com
• Phone: 4143577525
• Email: info@bioresearchinc.com
• Phone: 4143577525
• Email: info@bioresearchinc.com
• Phone: 4143577525
• Email: info@bioresearchinc.com
• Phone: 4143577525
• Email: info@bioresearchinc.com
• Phone: 4143577525
• Email: info@bioresearchinc.com
• Phone: 4143577525
• Email: info@bioresearchinc.com
• Phone: 4143577525
• Email: info@bioresearchinc.com
• Phone: 4143577525
• Email: info@bioresearchinc.com
• Phone: 4143577525
• Email: info@bioresearchinc.com
• Phone: 4143577525
• Email: info@bioresearchinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003499948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981563

FDA Product Code

• KZM: Device, Muscle Monitoring

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: 2023-06-30
• Device Publish Date: 2023-06-22

Devices Manufactured by Bio-Research Associates, Inc.

• 00860009598201 - Taylor Industries: 2023-08-25
• 00860003499900 - BioEMG: 2023-06-30 Indications for use: 8 channel EMG Amplifier 1. To record electrical activity of muscles of the stomatognathic system, especiall
• 00860003499917 - JT-3D: 2023-06-30 The Jaw Tracker-3D is a non-invasive, non-painful test that records incisor-point movements in three dimensions. A small magnet,
• 00860003499924 - BioJVA: 2023-06-30 Indications for use: 2 channel JVA amplifier 1. To record and display sounds/vibrations from the temporomandibular joints. 2. To
• 00860003499931 - BioJVA: 2023-06-30
• 00860003499948 - BioPAK: 2023-06-30
• 00860003499948 - BioPAK: 2023-06-30
• 00860003499955 - M-Scan: 2023-06-30 M-Scan is specifically designed to record craniofacial muscle activity during function and resting.
• 00860003499962 - M-Scan: 2023-06-30 M-Scan is specifically designed to record craniofacial muscle activity during function and resting.