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 Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform
Primary Device ID00850017250079
NIH Device Record Keya73ae03c-bef2-41c4-b738-5c50b25cab6e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBalance Advantage Computerized Dynamic Posturography System
Version Model Number97P-0036
Company DUNS619142540
Company NameBERTEC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850017250079 [Primary]
GS100850017250079 [Primary]
GS100850017250079 [Primary]
GS100850017250079 [Primary]
GS100850017250079 [Primary]
GS100850017250079 [Primary]
GS100850017250079 [Primary]
GS100850017250079 [Primary]
GS100850017250079 [Primary]
GS100850017250079 [Primary]
GS100850017250079 [Primary]
GS100850017250079 [Primary]
GS100850017250079 [Primary]
GS100850017250079 [Primary]
GS100850017250079 [Primary]

FDA Product Code

KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-13
Device Publish Date2021-01-05

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00850017250079 - Balance Advantage Computerized Dynamic Posturography System2021-01-13The 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.
00850017250079 - Balance Advantage Computerized Dynamic Posturography System2021-01-13 The Computerized Dynamic Posturography (CDP ) system is a clinical balance assessment device that collects and analyzes force an

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