Balance Advantage Computerized Dynamic Posturography System

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…

Registry build 21.09.26

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.

1manufacturer
1catalogue number

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code KHX
Manufacturer City Province Registered as Device types
Fourier Intelligence Inc. Shanghai Shanghai Private-label distributor 6

Record

Regulatory record for Balance Advantage Computerized Dynamic Posturography System
Listed by Bertec Corp., United States
FDA product code KHX
Device type Platform, Force-Measuring
Device class Class 1
Regulation 21 CFR 890.1575
Establishment Manufacturer
Premarket notification Exempt
Record published 2021-01-05

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Balance Advantage Computerized Dynamic Posturography System
Catalogue number Size Status
97P-0036 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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BTrackS Balance Plate Balance Tracking Systems Incorporated 1
MotionVR Virtualis 1
FDM-SX Zebris Medical Gmbh 1

Showing 12 of 35. All products under Platform, Force-Measuring

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer