Data / Medical devices / United States / Plandocs Usa, Inc.
Plandocs Usa, Inc.: FDA-registered device maker in Orange, CA, United States, 2 510(k) clearances
Plandocs Usa, Inc. is registered with the FDA (registration 3030446758) in Orange, CA, United States. It lists 3 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 2, 2026.
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- FDA registration number
- 3030446758
- Address
- 500 N State College Blvd Ste 1100, Orange, CA, United States, 92868
- Owner or operator
- Plandocs USA, Inc. (Now JinuMedix Inc.) (10091336)
- Roles
- Repackager or relabeler
- First device listed
- March 25, 2025
- Registered through
- 2026
- Brand names listed
- DermiSync, Dr.pen A20, Lumeon_Pro, PD NANO CANNULA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Powered Microneedle Device | QAI | 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 |
|---|---|---|---|---|---|---|
| August 11, 2023 | K230420 | Dr. pen Microneedling System | QAI | Substantially Equivalent | Guangzhou Ekai Electronic Technology Co., Ltd. | accessdata.fda.gov |
| September 21, 2016 | K151090 | CPL Insulin Pen Needle | FMI | Substantially Equivalent | Cpl Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Cannula, Surgical, General & Plastic Surgery
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Powered Microneedle Device
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.