Data / Medical devices / United States / J&T Health and Wellness LLC
J&T Health and Wellness LLC: FDA-registered device maker in Saint Petersburg, FL, United States, 1 510(k) clearance
J&T Health and Wellness LLC is registered with the FDA (registration 1058796) in Saint Petersburg, FL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 10, 2018. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1058796
- FEI number
- 1000525872
- Address
- 2442 23rd St N, Saint Petersburg, FL, United States, 33713
- Owner or operator
- J&T Health and Wellness LLC dba ProSun International (9031097)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 12, 2018
- Registered through
- 2026
- Brand names listed
- Aquafrixio, Luxura, ProSun, ProSun Onyx, ProSun V3, RelaxSun, Sundream
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Booth, Sun Tan | LEJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | 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 |
|---|---|---|---|---|---|---|
| September 10, 2018 | K181455 | ProSun sunlamp products, Luxura sunlamp products | LEJ | Substantially Equivalent | Prosun International, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 31, 2023 | 92217 | Class II | Ongoing | ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device | In some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit. | accessdata.fda.gov |
| December 10, 2018 | 82346 | Class II | Terminated | ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, PROSU | ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output. | accessdata.fda.gov |
| December 2, 2017 | 78571 | Class II | Terminated | Sundream 12 V tanning bed | The 30 minute maximum tanning time has been reduced to 20 minutes. | accessdata.fda.gov |
Compare with other makers
Updated September 28, 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.