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
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adhesive Backed Thermal Skin Patches | OMW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Applicator, Ent | KCJ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Applicator, Vaginal | HGD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Attachment, Commode, Wheelchair | INB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Band Or Belt, Pelvic Support | ISR | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Complaint file establishment | accessdata.fda.gov |
| Brush, Dermabrasion, Manual | GED | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Cap, Cervical | HDR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Clinical Electronic Thermometer | SDV | 2 | Complaint file establishment | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Complaint file establishment | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Device, Acupressure | MVV | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dilator, Rectal | FFP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible | PEB | 2 | Complaint file establishment | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Complaint file establishment | accessdata.fda.gov |
| Massager, Therapeutic, Manual | LYG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Nasal Spray, Ent Delivery | KCO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Complaint file establishment | accessdata.fda.gov |
| Nursing Pad, Hydrogel | NTC | 1 | Complaint file establishment | accessdata.fda.gov |
| Orthosis, Abdominal | KTD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Complaint file establishment | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Paper, Obstetric Ph | LNW | 1 | Complaint file establishment | accessdata.fda.gov |
| Pump, Breast, Non-Powered | HGY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Ring, Teething, Fluid-Filled | KKO | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Complaint file establishment | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Complaint file establishment | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Complaint file establishment | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 23, 2023 | K222969 | FERTI-LILY Conception Cup | HDR | Substantially Equivalent | Rosesta Medical BV | accessdata.fda.gov |
| June 29, 2022 | K220289 | FridaMom Anti-Nausea Bands | MVV | Substantially Equivalent | Fridababy, LLC | accessdata.fda.gov |
| February 9, 2022 | K212705 | Actively Trying Personal Lubricant Unfragrance | PEB | Substantially Equivalent | CC Wellness, LLC | accessdata.fda.gov |
| December 22, 2017 | K172257 | TrueDX 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) | JHI | Substantially Equivalent | True Diagnostics, Inc. | accessdata.fda.gov |
| May 29, 1992 | K921099 | SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST | LCX | Substantially Equivalent | Syntron Bioresearch, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 27, 2020 | 84707 | Class II | Ongoing | 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 w | accessdata.fda.gov |
Compare with other makers
- All makers of Bottle, Collection, Vacuum
- All makers of Device, Acupressure
- All makers of Dilator, Rectal
- All makers of Elastomer, Silicone, For Scar Management
- All makers of Massager, Therapeutic, Electric
- All makers of Massager, Therapeutic, Manual
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.