Duns Number:062312574
Device Description: The Morning & Motion Sickness Band is an elasticated band that can be comfortably worn aro The Morning & Motion Sickness Band is an elasticated band that can be comfortably worn around the wrist. There is a plastic button-shaped stud inserted through the band. Morning & Motion Sickness Band are designed to be worn around the wrist where the stud exerts a pressure to the Nei-Kuan acupressure point.The Morning & Motion Sickness Band is a simple device used to control nausea and motion sickness without the use of drugs. The device is non-powered and operates by exerting pressure on acupressure points, as such it is non-invasive.
Catalog Number
996552
Brand Name
CVS Health
Version/Model Number
996552
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 21, 2016
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
-
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
K033268
Product Code
MVV
Product Code Name
Device, Acupressure
Public Device Record Key
de46fce0-0d9f-41bb-b55d-416ed81b08dc
Public Version Date
November 20, 2018
Public Version Number
4
DI Record Publish Date
September 21, 2016
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |