Bertec Head Mounted Display System (HMD)

Basic Information

• Brand Name: Bertec Head Mounted Display System (HMD)
• Primary DI: 00850017250116
• Version / Model: 97P-0109
• Company Name: BERTEC CORPORATION
• Labeler DUNS: 619142540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-08
• Public Version: 2
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: 1b7ac179-54db-4232-8f8e-dae08e522026

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

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ISD	Exerciser, Measuring	Physical Medicine	890.5360	2
KHX	Platform, Force-Measuring	Physical Medicine	890.1575	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850017250116	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]