Data / Medical devices / United States / New Horizon Medical Solutions
New Horizon Medical Solutions: FDA-registered device maker in Las Vegas, NV, United States, 3 510(k) clearances
New Horizon Medical Solutions is registered with the FDA (registration 3009518429) in Las Vegas, NV, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 21, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3009518429
- Address
- 8395 W Sunset Rd Ste 200, Las Vegas, NV, United States, 89113
- Owner or operator
- New Horizon Health Care Management (10095696)
- Roles
- Specification developer
- First device listed
- April 15, 2026
- Registered through
- 2026
- Brand names listed
- PWD Platform Wound Dressing, Viz Wound Visualization NPWT System, Viz Wound Dressing 3" x 5" Oblong, Xpansion Micro-Autografting Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dermatome | GFD | 1 | Specification developer | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 21, 2022 | K212359 | PWD Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | Applied Tissue Technologies, LLC | accessdata.fda.gov |
| July 2, 2019 | K191460 | PWD Platform Wound Dressing 3 x 5 Oblong | OMP | Substantially Equivalent | Applied Tissue Technologies, LLC | accessdata.fda.gov |
| January 11, 2019 | K182409 | Applied Tissue Technologies PWD Platform Wound Dressing | OMP | Substantially Equivalent | Applied Tissue Technologies, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 21, 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.