AccessGUDID - DEVICE: Homedics (00031262112286)

GUDID

Device Identifier (DI) Information

Brand Name: Homedics
Version or Model: SPE-320HJ
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.

Primary DI Number: 00031262112286
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544356011 *Terms of Use

Device Description: eye massager with heat

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?
67203	Wearable electric massager	An electrically-powered device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It is typically in the form of a wearable wrap containing vibrating nodes that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment; it may additionally provide heat. This is a home-use device.	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: 8af1ed10-cae5-4e6b-bef1-7720685e2de9
Public Version Date: November 07, 2024
Public Version Number: 1
DI Record Publish Date: October 30, 2024