Duns Number:010000704
Device Description: Over the counter Red/IR LED Heating device for minor aches and pains, temporary increase i Over the counter Red/IR LED Heating device for minor aches and pains, temporary increase in circulation.
Catalog Number
-
Brand Name
Relaxatio
Version/Model Number
RX100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 01, 2031
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
Yes
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
9f9df58f-8920-44f5-bfc3-1e28480f6d0d
Public Version Date
July 08, 2022
Public Version Number
1
DI Record Publish Date
June 30, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |