Assess Balance

GUDID 00860010129111

Balance Tracking Systems Incorporated

Posturography system application software

• Primary Device ID: 00860010129111
• NIH Device Record Key: badb30f6-d00c-41a8-a8ca-2c550ca0d23d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assess Balance
• Version Model Number: Version 7
• Company DUNS: 079365006
• Company Name: Balance Tracking Systems Incorporated
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 1-888-811-0054
• Email: andy@balancetrackingsystems.com
• Phone: 1-888-811-0054
• Email: andy@balancetrackingsystems.com
• Phone: 1-888-811-0054
• Email: andy@balancetrackingsystems.com
• Phone: 1-888-811-0054
• Email: andy@balancetrackingsystems.com
• Phone: 1-888-811-0054
• Email: andy@balancetrackingsystems.com
• Phone: 1-888-811-0054
• Email: andy@balancetrackingsystems.com
• Phone: 1-888-811-0054
• Email: andy@balancetrackingsystems.com
• Phone: 1-888-811-0054
• Email: andy@balancetrackingsystems.com
• Phone: 1-888-811-0054
• Email: andy@balancetrackingsystems.com
• Phone: 1-888-811-0054
• Email: andy@balancetrackingsystems.com
• Phone: 1-888-811-0054
• Email: andy@balancetrackingsystems.com
• Phone: 1-888-811-0054
• Email: andy@balancetrackingsystems.com
• Phone: 1-888-811-0054
• Email: andy@balancetrackingsystems.com
• Phone: 1-888-811-0054
• Email: andy@balancetrackingsystems.com
• Phone: 1-888-811-0054
• Email: andy@balancetrackingsystems.com
• Phone: 1-888-811-0054
• Email: andy@balancetrackingsystems.com
• Phone: 1-888-811-0054
• Email: andy@balancetrackingsystems.com
• Phone: 1-888-811-0054
• Email: andy@balancetrackingsystems.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010129111 [Primary]

FDA Product Code

• KHX: Platform, Force-Measuring

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: 2023-04-07
• Device Publish Date: 2023-03-30

Devices Manufactured by Balance Tracking Systems Incorporated

• 00860010129104 - BTrackS Balance Plate: 2023-04-07
• 00860010129111 - Assess Balance: 2023-04-07
• 00860010129111 - Assess Balance: 2023-04-07