Wellsystem

Basic Information

• Brand Name: Wellsystem
• Primary DI: EJKP100003908A0
• Version / Model: Wave Touch
• Company Name: JK-Products GmbH
• Labeler DUNS: 316232073
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-30
• Public Version: 1
• Public Version Date: 2022-10-10
• Public Version Status: New
• Public Device Record Key: 1e043d42-f856-406d-bf66-e22eb2bcf74b

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
ISA	Massager, Therapeutic, Electric	Physical Medicine	890.5660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
14450	Hydrotherapy bath/tank	A bathtub or tank designed to be filled with warm water and occupied by a patient for the application of various forms of physical hydrotherapy such as water jet massage or aquatic exercise, typically to help treat musculoskeletal pain and stiffness or for physical rehabilitation; it is not dedicated to flotation therapy. It may have built-in water jet nozzles or an external heating/pump system to heat and circulate the water (whirlpool effect). This device is intended to be used in a healthcare facility.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EJKP100003908A0	HIBCC