Dynavision

Basic Information

• Brand Name: Dynavision
• Primary DI: 00860011067641
• Version / Model: D2 220v with Mobile Stand
• Company Name: Dynavision Global Holdings, LLC
• Labeler DUNS: 079220528
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-10
• Public Version: 1
• Public Version Date: 2024-06-18
• Public Version Status: New
• Public Device Record Key: e4e8ebdc-d8a2-461b-8074-1373f6c73cff

Device Description

Attention Task Performance Recorder

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: No
• 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
LQD	Recorder, Attention Task Performance	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
67212	Reaction trainer	An electrically-powered device intended to assess and train sensory-motor integration (e.g., visual reaction time, eye-hand coordination) and peripheral awareness for the purposes of neurorehabilitation as well as athletic and military performance improvement. It is in the form of an upright board (e.g., touchscreen) with a number of light-up buttons; the user is instructed to focus on the screen and press the buttons as they are illuminated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860011067641	GS1

Premarket Submissions

Submission Number	Supplement Number
K911938	000