AccessGUDID - DEVICE: Joovv Solo (00855501008013)

GUDID

Device Identifier (DI) Information

Brand Name: Joovv Solo
Version or Model: EA-150660850
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: JOOVV, INC.

Primary DI Number: 00855501008013
Issuing Agency: GS1
Commercial Distribution End Date: August 01, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 104893063 *Terms of Use

Device Description: The Joovv Solo is a red/infrared LED heating device for therapeutic pain relief.

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):	Yes
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?
35147	Musculoskeletal infrared phototherapy unit, non-wearable	An electrically-powered device intended for use in the home or clinical setting to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILY	Lamp, Infrared, Therapeutic Heating

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: 24a2fdb9-5535-4b2d-8f43-83c5733e7e9b
Public Version Date: April 18, 2025
Public Version Number: 3
DI Record Publish Date: November 12, 2019