FDA.reportPublic FDA data

TumEase

Primary DI
00860002270203
Brand
TumEase
Company
MUMEASE LLC
Model
B1
Device description
Dot and Checkered Acupressure Bracelets
Published
2020-05-11
Public version status
New
Distribution status
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
K193374000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193374000TumEase Acupressure BraceletsMumease2020-03-04MVV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002270203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002270203008600022702038600022702030860002270203

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
101956090
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860002270210TumEaseB22020-05-11
00860002270227TumEaseB32020-05-11
00860002270234TumEaseB42020-05-11
00860002270241TumEaseB52020-05-11
00860002270258TumEaseB62020-05-11
00860000032803MumEaseAB12020-04-09

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
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