NA

Basic Information

• Brand Name: NA
• Primary DI: 06944413808164
• Version / Model: TM-400 Treadmill
• Company Name: Edan Instruments, Inc.
• Labeler DUNS: 529173163
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-07
• Public Version: 3
• Public Version Date: 2020-05-19
• Public Version Status: Update
• Public Device Record Key: a238a7dc-8e5e-4ea7-9f4a-e9badb5d220a

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
17895	Cardiopulmonary stress exercise trolley	A cart that accommodates an ergometer (e.g., a static bicycle or treadmill) and the necessary equipment to measure metabolic energy expenditure and cardiovascular/respiratory function during exercise. This trolley (cart) is used for periodic assessment of the patient's progress in cardiac and pulmonary rehabilitation programs to determine energy expenditure levels.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06944413808164	GS1