FDA.reportPublic FDA data

Frida

Primary DI
00810028771697
Brand
Frida
Company
Fridababy, LLC
Model
02501800
Device description
Anti-Nausea Bands
Published
2025-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVVDevice, Acupressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVVDevice, AcupressureUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220289000FridaMom Anti-Nausea BandsFridababy, LLC2022-06-29MVV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810028771694PackageGS14In Commercial Distribution
00810028771697PrimaryGS10
00810028777972Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081002877169410810028771694
00810028771697008100287716978100287716970810028771697
00810028777972008100287779728100287779720810028777972

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

Contacts#

Phone, Email table
PhoneEmail
1-833-983-3743fussbuster@fridababy.com

Regulatory Flags#

DUNS number
783729598
Device count
2

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810028777958Frida039001002025-07-12
00810028777965Frida009001002025-07-12
00810028778009Frida014001001000000612025-07-12
10810028770086Frida039001002025-07-12
10810028777962Frida009001002025-07-12
10810028770611Frida014001001000000612025-07-12
00810028770508Frida050014012025-07-02
10810028770505Frida050014012025-07-02
00810028776166Frida1000018102024-09-12
10810028774084Frida5000012872024-09-12
00810028774124Frida Fertility5000012692023-12-05
00810028776739Fridababy123001002025-01-08
10810028774121Frida Fertility5000012692023-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00008727001027Sea-BandSEA-BAND LIMITEDMVV2025-08-06
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