BioJVA

GUDID 00860003499924

Indications for use: 2 channel JVA amplifier 1. To record and display sounds/vibrations from the temporomandibular joints. 2. To aid the clinician in their analysis of a joint sound/vibration by allowing them to see the waveform in various standard plots. 3. To aid the clinician in comparing a patient's current stand plots to previous recordings before, during, and after treatment. 4. To provide numerical values that can be used to quantify the physical characteristics of the sounds/vibrations, allowing intra-patient comparisons (only) by the clinician.

Bio-Research Associates, Inc.

Jaw physiology evaluation system

• Primary Device ID: 00860003499924
• NIH Device Record Key: 8a9def97-4af6-4313-a4ea-f88519b64a3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioJVA
• Version Model Number: Amplifier 1608FS
• 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: 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: 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	00860003499924 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905657

FDA Product Code

• NFQ: Device, Dental Sonography, For Monitoring Jaw Sounds

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

On-Brand Devices [BioJVA]

• 00860009598218: Indications for use: 2 channel JVA amplifier 1. To record and display sounds/vibrations from the
• 00860003499931: Headset
• 00860003499924: Indications for use: 2 channel JVA amplifier 1. To record and display sounds/vibrations from the