Trackmaster

Basic Information

• Brand Name: Trackmaster
• Primary DI: 00860176000613
• Version / Model: TMX428 220V
• Company Name: Full Vision, Inc.
• Labeler DUNS: 007237613
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-30
• Public Version: 1
• Public Version Date: 2023-01-09
• Public Version Status: New
• Public Device Record Key: ace030b3-f571-48eb-9c9a-6823bcc8530a

Device Description

TMX428 220V Trackmaster Treadmill

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
IOL	Treadmill, Powered	Physical Medicine	890.5380	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36679	Cardiopulmonary stress exercise treadmill	An electrically-powered device designed to be used as a component of a stress test system that permits the evaluation of a patient's physiologic response to physical stress (e.g., workload testing of the cardiac and/or pulmonary disorders/function). It is designed for walking, jogging, or running on a moving belt that facilitates physical exercise while the patient remains on the spot (i.e., treadmill). It consists of an endless, continuous track (e.g., a shock-absorbing rubber belt rotating on rollers) that rotates at varying speeds and elevation, electric motors, and controls. It will typically incorporate front and side-mounted rails to allow the user to steady themselves.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860176000613	GS1