FridaBaby LLC
Miami, FL, US
FRIDABABY, LLC appears in FDA device records in Miami, FL. FDA records list one 510(k) clearance, no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for FridaBaby LLC in 2022.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2022 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3030726486 | 3030726486 | FRIDABABY, LLC | 11007 Development Way, Jacksonville, FL 32220 US | 2026 | and 12 more, listed in full below |
| 3005630901 | 3005630901 | FridaBaby LLC | 82 NE 26th St, Miami, FL 33137 US | 2026 | and 25 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OMWAdhesive Backed Thermal Skin Patches
- KCJApplicator, Ent
- HGDApplicator, Vaginal
- INBAttachment, Commode, Wheelchair
- ISRBand Or Belt, Pelvic Support
- KDQBottle, Collection, Vacuum
- GEDBrush, Dermabrasion, Manual
- HDRCap, Cervical
- BSYCatheters, Suction, Tracheobronchial
- SDVClinical Electronic Thermometer
- KYWContainer, Liquid Medication, Graduated
- NNIContainer, Specimen, Non-Sterile
- MVVDevice, Acupressure
- FFPDilator, Rectal
- KYXDispenser, Liquid Medication
- MDAElastomer, Silicone, For Scar Management
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- PEBLubricant, Personal, Gamete, Fertilization, And Embryo Compatible
- ISAMassager, Therapeutic, Electric
- LYGMassager, Therapeutic, Manual
- KCONasal Spray, Ent Delivery
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- NTCNursing Pad, Hydrogel
- KTDOrthosis, Abdominal
- IMDPack, Hot Or Cold, Disposable
- IMEPack, Hot Or Cold, Reusable
- HHDPad, Menstrual, Unscented
- LNWPaper, Obstetric Ph
- HGYPump, Breast, Non-Powered
- KKORing, Teething, Fluid-Filled
- KGXTape And Bandage, Adhesive
- NGETest, Luteinizing Hormone (Lh), Over The Counter
- EFWToothbrush, Manual
- JEQToothbrush, Powered
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1103-2020 | fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once | FridaBaby 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 welded inside the brush head. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain