J&T Health and Wellness LLC
Saint Petersburg, FL, US
J&T Health and Wellness LLC appears in FDA device records in Saint Petersburg, FL. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to J&T Health and Wellness LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Prosun International, LLC510(k), enforcement report, recall
510(k) clearance history
FDA records hold 1 510(k) clearance for J&T Health and Wellness LLC in 2018.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1058796 | 1000525872 | J&T Health and Wellness LLC | 2442 23rd St N, Saint Petersburg, FL 33713 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2636-2023 | 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. | Class II | Open, Classified | |
| Z-1177-2019 | ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following: PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE (TMAX READY), PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE, PROSUN V3 42 HIGH INTENSIVE (160W) RED, PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE TMAX READY | ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output. | Class II | Terminated | |
| Z-1176-2019 | 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, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin | ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output. | Class II | Terminated | |
| Z-0319-2018 | Sundream 12 V tanning bed | The 30 minute maximum tanning time has been reduced to 20 minutes. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain