LARGE ROLLER W/E-JACK

Basic Information

• Brand Name: LARGE ROLLER W/E-JACK
• Primary DI: 14897076720481
• Version / Model: Drum.Large
• Company Name: TENS PLUS INDUSTRIAL COMPANY
• Labeler DUNS: 663211978
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-14
• Public Version: 1
• Public Version Date: 2022-11-22
• Public Version Status: New
• Public Device Record Key: dbcc79b8-2cb3-416c-aea2-c7471fa91f9a

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
LYG	Massager, Therapeutic, Manual	Physical Medicine	890.5660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45168	Static magnetic massager	A hand-held device designed to be moved over body surfaces that uses static magnets (e.g., rotating magnetic balls) intended to produce a weak magnetic flux over a superficial body site to provide comfort and localized temporary relief from minor aches and pains. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	14897076720481	GS1