Bertec Balance Advantage Computerized Dynamic Posturography (CDP) System

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 97P-0036Model Type 1001

by Bertec Corporation

Identity

Trade Name: Balance Advantage Computerized Dynamic Posturography System FDA UDI
Generic Name: Posturography system platform FDA UDI
Device Name: Bertec Balance Advantage Computerized Dynamic Posturography (CDP) System EUDAMED
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. FDA UDI
Model / Reference: Type 1001 EUDAMED
97P-0036 EUDAMEDFDA UDI
Description: 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. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850017250079 EUDAMEDFDA UDI
Basic UDI-DI: 0850017250TYPE1001K3 EUDAMED
FDA Product Code: KHX FDA UDI
EMDN Code: Z12140404 POSTUROGRAPHY SYSTEMS EUDAMED
GMDN Term: Posturography system platform FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 890.1575 FDA UDI
Market of Registration: Spain EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Bertec Balance Advantage Computerized Dynamic Posturography (CDP) System by Bertec Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	0850017250TYPE1001K3	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Bertec Corporation
EUDAMED SRN: US-MF-000008643
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (2)

EUDAMED f5e503b4-553d-46ff-b572-d8dd02c02de1 61 fields · synced Jul 10, 2026
FDA UDI a73ae03c-bef2-41c4-b738-5c50b25cab6e 34 fields · synced May 30, 2026