Homedics

Basic Information

• Brand Name: Homedics
• Primary DI: 00031262104151
• Version / Model: FB-52J-PK-2
• Company Name: Smart Home Branch of Zhangzhou Easepal Industrial Corporation
• Labeler DUNS: 416114043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-01
• Public Version: 1
• Public Version Date: 2021-06-09
• Public Version Status: New
• Public Device Record Key: 4c03c6e5-5472-4382-9ab3-0cec0d76999c

Device Description

BUBBLE BLISS DELUXE FOOTBATH

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
ISA	Massager, Therapeutic, Electric	Physical Medicine	890.5660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36557	Foot bath	A mains electricity (AC-powered) device designed to be filled with water to provide therapeutic heat treatment specifically to the feet. It typically consists of a unit with a wide stable base that stands on the floor and includes a shallow receptacle in the centre for the user to place their feet. It has a heating element with thermostat that heats the water to a selected temperature. Some types may have therapeutic foot massage capabilities. This device is intended to relieve foot pain (e.g., ankle joint pain from sprains), as well as headaches, coughs, and other cold symptoms.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00031262104151	GS1