FDA.reportPublic FDA data

CVS Health

Primary DI
00050428269381
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
996552
Catalog number
996552
Device description
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.
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00050428269381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00050428269381000504282693810504282693810050428269381

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
062312574
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00050428280669CVS HealthCVS5248V12026-06-04
00050428359112CVS HealthCVS739091V12026-06-04
00050428453599CVS HealthCVS9107552026-06-04
10050428265106CVS Glucose Meter8000-107532021-03-22
00050428050460CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428082102CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428087268CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428087589CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428049556CVS Health6 Days Sooner Pregnancy TestN/A2026-06-02
00050428142516CVS0504281425162026-05-28
00050428044940CVS6158032026-05-26
00050428045770CVS6162732026-05-26
00050428046715CVS6162742026-05-26
00050428344781CVS0504283447812026-05-25
00050428250181CVS Health4969912023-09-01
00050428340769CVS Health 0504283407692026-05-20
00050428490730CVS Health5645702021-04-08
00050428000021CVS Health 0504280000212026-05-19
00050428373927CVS Health 9377672026-04-27
00050428142530CVS0504281425302026-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00008727001027Sea-BandSEA-BAND LIMITEDMVV2025-08-06
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
00008727000013Sea-BandSEA-BAND LIMITEDMVV2016-09-09
00008727000020Sea-BandSEA-BAND LIMITEDMVV2016-09-09
00008727000372Sea-BandSEA-BAND LIMITEDMVV2016-09-09