Duns Number:238545748
Device Description: The Sea-Band is an elasticated band that can be comfortably worn around the wrist. There i The Sea-Band is an elasticated band that can be comfortably worn around the wrist. There is a plastic button-shaped stud inserted through the band. Sea-Bands are designed to be worn around the wrist where the stud exerts a pressure to the Nei-Kuan acupressure point.The Sea-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, and non-sterile.
Catalog Number
-
Brand Name
Sea-Band
Version/Model Number
Mama
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
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
ee0afbab-9c24-4e6a-92e0-b533d95525a8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 09, 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 |
|---|---|---|
| U | Unclassified | 3 |