Sea-Band

Primary DI
00008727001027
Brand
Sea-Band
Company
SEA-BAND LIMITED
Model
XL
Device description
The XL Sea-Band is an elasticated band that can comfortably worn around the wrists with a circumference over 8 inches. There is a plastic button-shaped stud inserted through the band. Sea-Bands are designed to be worn around each wrist where the stud exerts 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.
Published
2025-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MVVDevice, Acupressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVVDevice, AcupressureUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033268000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033268000SEA-BANDSea-Band UK , Ltd.2004-01-07MVV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00008727001027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00008727001027000087270010270087270010270008727001027

GMDN Terms#

Term, Definition table
TermDefinition
Acupressure wristbandA device designed to be worn on the wrist(s) for the application of pressure to the Nei-kuan (P6) acupressure point, the area identified to help relieve the sensation of nausea. The device is typically an adjustable strap made of medical grade thermoplastic material that includes a mechanical pressure dial (a notched wheel) that can be manually rotated by the user to increase or decrease the applied acupressure. It is intended to alleviate nausea caused by various conditions including pregnancy (morning sickness), motion sickness (travel sickness), post anaesthesia sickness, and chemotherapy sickness. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
238545748
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00008727000013Sea-BandAdult2016-09-09
00008727000020Sea-BandChild2016-09-09
00008727000372Sea-BandMama2016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810028771697FridaFridababy, LLCMVV2025-07-02
00011822820134RITEAIDRITE AID CORPORATIONMVV2021-12-03
20011822820138RITEAIDRITE AID CORPORATIONMVV2021-12-03
00025715688404FlentsAPOTHECARY PRODUCTS, LLCMVV2020-10-28
20025715688408FlentsAPOTHECARY PRODUCTS, LLCMVV2020-10-28
00079573108512CORE VALUESAPOTHECARY PRODUCTS, LLCMVV2020-08-31
10079573108519CORE VALUESAPOTHECARY PRODUCTS, LLCMVV2020-08-31
00079573101988Acu-Life (HE)APOTHECARY PRODUCTS, LLCMVV2020-07-31
10079573101985Acu-Life (HE)APOTHECARY PRODUCTS, LLCMVV2020-07-31
00311917156064WALGREENSWALGREEN CO.MVV2020-07-22
20079573000599WALGREENSWALGREEN CO.MVV2020-07-22
00860002270203TumEaseMUMEASE LLCMVV2020-05-11
00860002270210TumEaseMUMEASE LLCMVV2020-05-11
00860002270227TumEaseMUMEASE LLCMVV2020-05-11
00860002270234TumEaseMUMEASE LLCMVV2020-05-11
00860002270241TumEaseMUMEASE LLCMVV2020-05-11
00860002270258TumEaseMUMEASE LLCMVV2020-05-11
00860000032803MumEaseMUMEASE LLCMVV2020-04-09
00050428269381CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDMVV2016-09-21
00008727000013Sea-BandSEA-BAND LIMITEDMVV2016-09-09
00008727000020Sea-BandSEA-BAND LIMITEDMVV2016-09-09
00008727000372Sea-BandSEA-BAND LIMITEDMVV2016-09-09