Data / Medical devices / United States / Primo Passi
Primo Passi: FDA-registered device maker in Orlando, FL, United States, 3 510(k) clearances
Primo Passi is registered with the FDA (registration 3034993050) in Orlando, FL, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 9, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3034993050
- Address
- 7524 Currency Dr., Orlando, FL, United States, 32809
- Owner or operator
- Primo Passi (10092542)
- Roles
- Repackager or relabeler
- First device listed
- March 14, 2025
- Registered through
- 2026
- Brand names listed
- Primo Passi Ear and Forehead Thermomter, Primo Passi Electric Nail Filer, Primo Passi Lactation Massager, Primo Passi Portable Dual Charge Electric Breast Pump, Primo Passi Wearable Breast Pump
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Grooming | ILW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| December 9, 2022 | K221598 | Wearable breast pump | HGX | Substantially Equivalent | Mayborn (Uk) Limited | accessdata.fda.gov |
| February 24, 2015 | K142479 | MEGNA BREAST PUMPS | HGX | Substantially Equivalent | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | accessdata.fda.gov |
| November 12, 2013 | K131243 | NON-CONTACT INFRARED THERMOMETER | FLL | Substantially Equivalent | Shenzhen Jumper Medical Equipment Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Breast, Powered
- All makers of Continuous Measurement Thermometer
- All makers of Adaptor, Grooming
- All makers of Massager, Therapeutic, Electric
Updated December 9, 2022. 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.