Duns Number:104893063
Device Description: The Joovv Mini is a red/infrared LED heating device for therapeutic pain relief.
Catalog Number
-
Brand Name
Joovv Mini
Version/Model Number
EA-060660850
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
8fd33be4-9cef-41d9-bcad-86ae7c041b1e
Public Version Date
August 03, 2020
Public Version Number
2
DI Record Publish Date
November 12, 2019
Package DI Number
10855501008003
Quantity per Package
5
Contains DI Package
00855501008006
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 |