Duns Number:104893063
Device Description: The Joovv Go NIR is a rechargeable, battery powered infrared LED heating device for therap The Joovv Go NIR is a rechargeable, battery powered infrared LED heating device for therapeutic pain relief.
Catalog Number
-
Brand Name
Joovv Go NIR
Version/Model Number
EA-012850000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 01, 2020
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
d9ac8a4e-5b99-41df-867d-72899383a733
Public Version Date
August 03, 2020
Public Version Number
4
DI Record Publish Date
November 12, 2019
Package DI Number
10855501008225
Quantity per Package
20
Contains DI Package
00855501008228
Package Discontinue Date
August 01, 2020
Package Status
Not in Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |