Balance Advantage Computerized Dynamic Posturography System

GUDID 00850017250079

The Computerized Dynamic Posturography (CDP ) system is a clinical balance assessment device that collects and analyzes force and moment data from a balance plate. The balance plate is seated in a dynamic chassis that can move in both translational and rotational directions, under control of the Balance Advantage (BA) software program. The BA software contains both assessment and training modules that can be used during each session. Assessments have set run-times during which they collect data after the “Start” button is pressed, while trainings have customizable run-times varying from 1 minute to 15 minutes. The system is intended to be used by trained clinicians in a hospital or clinical (physical therapy or ENT) environment who operate the software and ensure the safety of the patient. The patient being assessed on the system is placed in a harness. There are three different harness sizes with varying weight limits that can be purchase with the system; standard harness supports up to 300lbs, pediatric is up to 100lbs, and the bariatric supports up to 450lbs. The mechanical components of the system are designed to support up to 500lb patients.

BERTEC CORPORATION

Posturography system platform

• Primary Device ID: 00850017250079
• NIH Device Record Key: a73ae03c-bef2-41c4-b738-5c50b25cab6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balance Advantage Computerized Dynamic Posturography System
• Version Model Number: 97P-0036
• 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	00850017250079 [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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