Data / Medical devices / United States / Hygenix Health Solutions LLC
Hygenix Health Solutions LLC: FDA-registered device maker in Torrance, CA, United States, 1 510(k) clearance
Hygenix Health Solutions LLC is registered with the FDA (registration 3016247944) in Torrance, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 11, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016247944
- Address
- 390 Amapola Ave Ste 4, Torrance, CA, United States, 90501
- Owner or operator
- Hygenix Health Solutions LLC (10092720)
- Roles
- Manufacturer
- First device listed
- February 10, 2025
- Registered through
- 2026
- Brand names listed
- Hygenix
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mask, Surgical | FXX | 2 | Manufacturer | 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 11, 2023 | K232797 | Hygenix | FXX | Substantially Equivalent | Shenzhen Hygenix Industrial Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 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.