Data / Medical devices / United States / Sunshine USA, LLC
Sunshine USA, LLC: FDA-registered device maker in Jc, TN, United States, 2 510(k) clearances
Sunshine USA, LLC is registered with the FDA (registration 3009973354) in Jc, TN, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 19, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009973354
- Address
- 2225 Eddie Williams Rd, Jc, TN, United States, 37601
- Owner or operator
- Sunshine USA, LLC (10042603)
- Roles
- Manufacturer
- First device listed
- February 28, 2020
- Registered through
- 2026
- Brand names listed
- Sunfire, Sunshine USA, Velara Ascend 48, Velara Elite 32, Velara Lounge 24
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Booth, Sun Tan | LEJ | 2 | Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 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 |
|---|---|---|---|---|---|---|
| April 19, 2018 | K180576 | Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) | LEJ | Substantially Equivalent | Lpi, Inc. | accessdata.fda.gov |
| May 20, 2016 | K152423 | Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy | LEJ | Substantially Equivalent | Sunfire Industries, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 19, 2018. 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.