AccessGUDID - DEVICE: Bertec Head Mounted Display System (HMD) (00850017250116)

GUDID

Device Identifier (DI) Information

Brand Name: Bertec Head Mounted Display System (HMD)
Version or Model: 97P-0109
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BERTEC CORPORATION

Primary DI Number: 00850017250116
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 619142540 *Terms of Use

Device Description: Bertec Balance Advantage Head Mounted Display (HMD) system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate with Head Mounted Display (HMD) to enhance clinical balance assessment and training.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47518	Biomechanical function analysis/rehabilitation software	A software package intended to be used by patients and clinicians to receive and display a patient’s physical exercise/movement/action data [e.g., kinesiology/gait data (walking speed or distance)] to facilitate analysis as part of physical assessment/rehabilitation. It is intended to be used while using an interactive rehabilitation system, biomechanical function analysis system and/or kinesiology recorder (ambulatory or implantable). It might be intended to function in conjunction with a motion-sensing system/device or limb-support robotic system, and may be capable of storing and/or enable viewing of patient performance data.	Active	false
17242	Posturography system	An assembly of devices designed to test a patient's sensory, voluntary, and/or reflexive motor control of balance and mobility providing biofeedback for rehabilitation of balance problems. The patient is placed on a dedicated platform equipped with built-in sensors, transducer and/or force plates that register movement when he/she adjusts his/her centre of gravity (COG) alignment according to the doctor's instructions, or, the platform provokes destabilizing perturbations and the output is recorded to a computer where they are graphically reproduced. This device is used, e.g., for motor control test (MCT), posture studies, balance, mobility training, and/or sense of equilibrium studies.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISD	Exerciser, Measuring
KHX	Platform, Force-Measuring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1b7ac179-54db-4232-8f8e-dae08e522026
Public Version Date: February 05, 2024
Public Version Number: 2
DI Record Publish Date: February 08, 2023