Duns Number:080294073
Device Description: Reliefband® Classic is a digital therapeutic device incorporated into a wristband which ha Reliefband® Classic is a digital therapeutic device incorporated into a wristband which has a stimulating electrode that is worn on the underside of the wrist. It provides relief from nausea and vomiting through gentle electrical stimulation of the median nerve. Batteries will last approximately 150 hours of active use at power level 3 or below. The batteries of Reliefband® are user replaceable. Replace batteries in unit when they become drained.
Catalog Number
1.5
Brand Name
Reliefband® Classic
Version/Model Number
1.5
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)
Yes
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
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
1b840467-95f2-44b7-946c-b78084b9611d
Public Version Date
July 07, 2021
Public Version Number
1
DI Record Publish Date
June 29, 2021
Package DI Number
20661168600019
Quantity per Package
12
Contains DI Package
00661168600015
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 |