Balance Advantage Prime IVR System

GUDID 00850017250062

Bertec Balance Advantage Prime IVR system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate with Immersive Virtual Reality (IVR) to enhance clinical balance assessment and training.

BERTEC CORPORATION

Posturography system platform

• Primary Device ID: 00850017250062
• NIH Device Record Key: 9e083987-0b7b-47a4-a648-38605a734671
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balance Advantage Prime IVR System
• Version Model Number: 97P-0072
• Company DUNS: 619142540
• Company Name: BERTEC CORPORATION
• 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: 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: 1-614-543-8099
• Email: support@bertec.com
• Phone: 1-614-543-8099
• Email: support@bertec.com
• Phone: 1-614-543-8099
• Email: support@bertec.com
• Phone: 1-614-543-8099
• Email: support@bertec.com
• Phone: 1-614-543-8099
• Email: support@bertec.com
• Phone: 1-614-543-8099
• Email: support@bertec.com
• Phone: 1-614-543-8099
• Email: support@bertec.com
• Phone: 1-614-543-8099
• Email: support@bertec.com
• Phone: 1-614-543-8099
• Email: support@bertec.com
• Phone: 1-614-543-8099
• Email: support@bertec.com
• Phone: 1-614-543-8099
• Email: support@bertec.com
• Phone: 1-614-543-8099
• Email: support@bertec.com
• Phone: 1-614-543-8099
• Email: support@bertec.com
• Phone: 1-614-543-8099
• Email: support@bertec.com
• Phone: 1-614-543-8099
• Email: support@bertec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017250062 [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: 2021-01-13
• Device Publish Date: 2021-01-05

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