AccessGUDID - DEVICE: Homedics (00031262110312)

GUDID

Device Identifier (DI) Information

Brand Name: Homedics
Version or Model: FB-50JB-BL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.

Primary DI Number: 00031262110312
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544356011 *Terms of Use

Device Description: Bubble Bliss Deluxe Footbath

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISA	Massager, Therapeutic, Electric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 321614e4-be92-41a3-b0b8-d5f0301b0994
Public Version Date: October 30, 2023
Public Version Number: 1
DI Record Publish Date: October 20, 2023