Data / Medical devices / United States / ZIZION GROUP Inc.
ZIZION GROUP Inc.: FDA-registered device maker in Boca Raton, FL, United States, 2 510(k) clearances
ZIZION GROUP Inc. is registered with the FDA (registration 3009435759) in Boca Raton, FL, United States. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 11, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3009435759
- Address
- 141 NW 20th Street Suite G1, Boca Raton, FL, United States, 33431
- Owner or operator
- Zizion Group Inc. (10043366)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- February 9, 2013
- Registered through
- 2026
- Brand names listed
- MedGeneRx PRP, MedGeneRx PRP BCCT, NanoPen Pro, PulseWave, RegenOMedix TD4B Centrifuge, RegenoSonic US-155, Yes PRP Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate | QBV | 1 | Complaint file establishment | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Complaint file establishment | accessdata.fda.gov |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Powered Microneedle Device | QAI | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Complaint file establishment | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Complaint file establishment | accessdata.fda.gov |
| Tube, Collection, Capillary Blood | GIO | 1 | 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 |
|---|---|---|---|---|---|---|
| August 11, 2023 | K230420 | Dr. pen Microneedling System | QAI | Substantially Equivalent | Guangzhou Ekai Electronic Technology Co., Ltd. | accessdata.fda.gov |
| February 28, 2018 | K172750 | Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) | IYO | Substantially Equivalent | Guangzhou Sonostar Technologies Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
- All makers of Platelet And Plasma Separator For Bone Graft Handling
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Tube, Collection, Capillary Blood
- All makers of Massager, Therapeutic, Electric
Updated August 11, 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.