Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1058796

FEI Number

1000525872

Entity Name

J&T Health and Wellness LLC

City/State/Country

Saint Petersburg, FL, US

Establishment Address

2442 23rd St N, Saint Petersburg, FL 33713, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

J&T Health and Wellness LLC dba ProSun International (Owner Number: 9031097)

Owner / Operator Contact Address

2442 23RD ST. NORTH, --, Saint Petersburg, FL 33713, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K181455

PMA Number

N/A

All Registered Proprietary Names

ProSun ProSun Onyx Luxura ProSun V3 Sundream RelaxSun

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LEJ	Booth, Sun Tan	General, Plastic Surgery	Class 2	878.4635	2021-01-11

Official Correspondent

JENNIFER HENKEMANS

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

J&T Health and Wellness LLC dba ProSun International

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K875190	Ultra Tan Intl. AB	ULTRA TAN PURPLE PRO	1988-01-14

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1058796. Last updated year: 2026. Please use registration number 1058796 when referencing this establishment in official correspondence.