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Data / Medical devices / United States / FridaBaby LLC

FridaBaby LLC: FDA-registered device maker in Miami, FL, United States, 5 510(k) clearances

FridaBaby LLC is registered with the FDA (registration 3005630901) in Miami, FL, United States. It lists 35 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 23, 2023. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
3005630901
Address
82 NE 26th St Suite 101, Miami, FL, United States, 33137
Owner or operator
Fridababy, LLC (10052488)
Roles
Complaint file establishment, Repackager or relabeler, Specification developer
First device listed
November 18, 2016
Registered through
2027
Brand names listed
12300100, 12101100, 3-in-1 Ear, Forehead, + Touchless Thermometer, 3-in-1 Nose, Nail + Ear Picker, 3-in-1 True Temp Thermometer, Baby Basics Kit, Baby Grooming Kit, Bath Accessories Kit, US,, Big Bundle of Joy and more

Devices it lists

DeviceProduct codeClassRoleSource
Adhesive Backed Thermal Skin PatchesOMW1Complaint file establishment, Specification developeraccessdata.fda.gov
Applicator, EntKCJ1Complaint file establishment, Specification developeraccessdata.fda.gov
Applicator, VaginalHGD1Complaint file establishment, Specification developeraccessdata.fda.gov
Attachment, Commode, WheelchairINB1Complaint file establishment, Specification developeraccessdata.fda.gov
Band Or Belt, Pelvic SupportISR1Complaint file establishment, Specification developeraccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Complaint file establishmentaccessdata.fda.gov
Brush, Dermabrasion, ManualGED1Complaint file establishment, Specification developeraccessdata.fda.gov
Cap, CervicalHDR2Complaint file establishment, Specification developeraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Complaint file establishment, Specification developeraccessdata.fda.gov
Clinical Electronic ThermometerSDV2Complaint file establishmentaccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Complaint file establishmentaccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Complaint file establishment, Specification developeraccessdata.fda.gov
Device, AcupressureMVVUComplaint file establishment, Specification developeraccessdata.fda.gov
Dilator, RectalFFP1Complaint file establishment, Specification developeraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Complaint file establishment, Specification developeraccessdata.fda.gov
Elastomer, Silicone, For Scar ManagementMDA1Complaint file establishment, Specification developeraccessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The CounterLCX2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Lubricant, Personal, Gamete, Fertilization, And Embryo CompatiblePEB2Complaint file establishmentaccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Complaint file establishmentaccessdata.fda.gov
Massager, Therapeutic, ManualLYG1Complaint file establishment, Specification developeraccessdata.fda.gov
Nasal Spray, Ent DeliveryKCO1Complaint file establishment, Specification developeraccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Complaint file establishmentaccessdata.fda.gov
Nursing Pad, HydrogelNTC1Complaint file establishmentaccessdata.fda.gov
Orthosis, AbdominalKTD1Complaint file establishment, Specification developeraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Complaint file establishmentaccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Complaint file establishment, Specification developeraccessdata.fda.gov
Pad, Menstrual, UnscentedHHD1Complaint file establishment, Specification developeraccessdata.fda.gov
Paper, Obstetric PhLNW1Complaint file establishmentaccessdata.fda.gov
Pump, Breast, Non-PoweredHGY1Complaint file establishment, Specification developeraccessdata.fda.gov
Ring, Teething, Fluid-FilledKKO2Complaint file establishment, Specification developeraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Complaint file establishmentaccessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The CounterNGE1Complaint file establishmentaccessdata.fda.gov
Toothbrush, ManualEFW1Complaint file establishment, Specification developeraccessdata.fda.gov
Toothbrush, PoweredJEQ1Complaint file establishment, Specification developeraccessdata.fda.gov
Visual, Pregnancy Hcg, Prescription UseJHI2Complaint file establishmentaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 23, 2023K222969FERTI-LILY Conception CupHDRSubstantially EquivalentRosesta Medical BVaccessdata.fda.gov
June 29, 2022K220289FridaMom Anti-Nausea BandsMVVSubstantially EquivalentFridababy, LLCaccessdata.fda.gov
February 9, 2022K212705Actively Trying Personal Lubricant UnfragrancePEBSubstantially EquivalentCC Wellness, LLCaccessdata.fda.gov
December 22, 2017K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)JHISubstantially EquivalentTrue Diagnostics, Inc.accessdata.fda.gov
May 29, 1992K921099SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TESTLCXSubstantially EquivalentSyntron Bioresearch, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
January 27, 202084707Class IIOngoingfridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at OnceFridaBaby has been made aware through customer reports that the product is being used outside of the labeled directions. Specifically, repeated chewing or biting on the SmileFrida, the ToothHugger has caused deterioration in the outer layer of the brush and in very rare occasions, may cause the hard plastic brush head to break, exposing a small metal piece waccessdata.fda.gov

Compare with other makers

Updated June 23, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.