Data / Medical devices / United States / Aura Wellness, LLC
Aura Wellness, LLC: FDA-registered device maker in Louisville, KY, United States, 2 510(k) clearances
Aura Wellness, LLC is registered with the FDA (registration 3018608545) in Louisville, KY, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 31, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018608545
- Address
- 2208 Plantside Drive, Louisville, KY, United States, 40299
- Owner or operator
- Aura Wellness, LLC (10081462)
- Roles
- Manufacturer
- First device listed
- December 3, 2025
- Registered through
- 2026
- Brand names listed
- Aura Wave, Aura Wellness ROC, Nova HD+
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electromagnetic Stimulator For Healthy Muscle Stimulation | SGT | 2 | Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 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 |
|---|---|---|---|---|---|---|
| August 31, 2026 | K262788 | Nova HD+ | SGT | Substantially Equivalent | Aura Wellness, LLC | accessdata.fda.gov |
| December 2, 2025 | K250896 | Aura Wave | SGT | Substantially Equivalent | Aura Wellness, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Lamp, Infrared, Therapeutic Heating
Updated August 31, 2026. 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.