Winner EVO Combo

Basic Information

• Brand Name: Winner EVO Combo
• Primary DI: 00853904006148
• Version / Model: 410-010
• Company Name: COMPASS HEALTH BRANDS CORP.
• Labeler DUNS: 827221698
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-21
• Public Version: 5
• Public Version Date: 2023-08-24
• Public Version Status: Update
• Public Device Record Key: bc626eeb-3340-4fc0-8a6f-ea569296bbe9
• Distribution End Date: 2018-12-31

Device Description

Winner EVO-CM2

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
LIH	Interferential Current Therapy	Neurology	882.5890	2
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	882.5890	2
IMG	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	Physical Medicine	890.5860	2
IPF	Stimulator, Muscle, Powered	Physical Medicine	890.5850	2
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	Physical Medicine	890.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17908	Physical therapy ultrasound/neuromuscular stimulation system	An assembly of devices that includes a neuromuscular electrical stimulator as an integral part of a therapeutic ultrasound system intended for the simultaneous delivery of ultrasound and electrical energies for physical therapy, typically to help prevent scar tissue formation in healing tissues and to help reduce muscle spasms and pain; it may in addition be capable of delivering either energy alone. The system is designed to produce a rhythmic contraction/release of injured muscles to promote the removal of metabolic by-products while applying ultrasound treatments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853904006148	GS1

Customer Contacts

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