Duns Number:080294073
Device Description: Reliefband® Premier Charcoal is a rechargeable, digital wearable device that is worn on th Reliefband® Premier Charcoal is a rechargeable, digital wearable device that is worn on the wrist. It consists of a hypoallergenic band with a control panel on top and two electrical contacts underneath. The two contacts must be placed firmly against the underside of your wrist at the P6 location. A fully charged battery will last for approximately 18 hours of continuous use at the mid-power level or below.
Catalog Number
2.0
Brand Name
Reliefband® Premier Charcoal
Version/Model Number
2.0 Charcoal
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
Yes
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
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
11d336fd-93d9-44f0-8a35-780db082e600
Public Version Date
July 07, 2021
Public Version Number
1
DI Record Publish Date
June 29, 2021
Package DI Number
30661168600023
Quantity per Package
6
Contains DI Package
00661168600022
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |