Cold Therapy System

Basic Information

• Brand Name: Cold Therapy System
• Primary DI: 06979165054569
• Version / Model: WLC-4
• Company Name: Shenzhen Shuichang Technology Co., Ltd
• Labeler DUNS: 554499344
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-30
• Public Version: 1
• Public Version Date: 2025-11-07
• Public Version Status: New
• Public Device Record Key: a38e4c37-5e36-4ec2-8cf1-98faf7f26d7e

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: 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
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	890.5720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64765	Hot/cold therapy system	An electrically-powered assembly of devices intended to apply controlled heat and cold therapy (including contrast therapy) to the surface of the body for a variety of physiotherapy applications such as treatment of musculoskeletal pain, inflammation reduction, and analgesia during intramuscular injection. It includes both a control unit and a handpiece with a heating/cooling endpiece; liquid coolant is used to provide the cooling effect.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06979165054569	GS1