BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RelaxSun

    Reg #: 1058796 · FEI: 1000525872 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    J&T Health and Wellness LLC
    Registration Number
    1058796
    FEI Number
    1000525872
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2442 23rd St N
    City
    Saint Petersburg
    State
    FL
    ZIP
    33713
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181455

    Owner / Operator

    Firm Name
    J&T Health and Wellness LLC dba ProSun International
    Operator Number
    9031097
    Address
    2442 23RD ST. NORTH, --
    City
    Saint Petersburg
    State
    FL
    Postal Code
    33713
    Country
    US
    Correspondent
    JENNIFER C HENKEMANS

    Products

    Device Name Product Code
    Booth, Sun Tan LEJ

    Proprietary Names

    RelaxSun Sundream ProSun ProSun V3 Luxura ProSun Onyx

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198