Data / Medical devices / United States / JTL Enterprises Inc.
JTL Enterprises Inc.: FDA-registered device maker in Clearwater, FL, United States, 1 510(k) clearance
JTL Enterprises Inc. is registered with the FDA (registration 1055758) in Clearwater, FL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 29, 1992. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1055758
- FEI number
- 1000111021
- Address
- 15395 Roosevelt Blvd, Clearwater, FL, United States, 33760
- Owner or operator
- JTL ENTERPRISES, INC. (9004597)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 7, 1992
- Registered through
- 2026
- Brand names listed
- AQUA SOOTHE, AQUAMED, AquaMed, ELECTRIC, HydroMassage, MASSAGER ( THERAPUTIC, RedZone Sauna, WATER
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer, Specification developer | 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 29, 1992 | K915729 | AUQASOOTHE/AQUA MED | ISA | Substantially Equivalent | Aquasoothe | accessdata.fda.gov |
Compare with other makers
Updated April 29, 1992. 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.