Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K240125
Therm-X (Home); Therm-X (AT) · Zenith Technical Innovations · decided 2024-06-21 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Therm-X | Therm-X Hand Garment | ZENITH TECHNICAL INNOVATIONS, LLC | ILO IRP JOW | 00850001096355 |
| Therm-X | Therm-X Hand SPU | ZENITH TECHNICAL INNOVATIONS, LLC | ILO IRP JOW | 00850001096324 |
| Therm-X | Therm-X Hand Garment | ZENITH TECHNICAL INNOVATIONS, LLC | ILO IRP JOW | 00850001096492 |
| Therm-X | Therm-X Half-Leg Garment | ZENITH TECHNICAL INNOVATIONS, LLC | ILO IRP JOW | 00850001096461 |
| Therm-X | Therm-X Butterfly Knee Small, SPU | ZENITH TECHNICAL INNOVATIONS, LLC | ILO IRP JOW | 00850001096577 |
| Therm-X | Therm-X AT | ZENITH TECHNICAL INNOVATIONS, LLC | ILO IRP JOW | 00850001096294 |
| Therm-X | Therm-X AT | ZENITH TECHNICAL INNOVATIONS, LLC | ILO IRP JOW | 00850001096386 |
| Therm-X | Therm-X Butterfly Knee Small, SPU | ZENITH TECHNICAL INNOVATIONS, LLC | ILO IRP JOW | 00850001096379 |
| Therm-X | Therm-X Hand SPU | ZENITH TECHNICAL INNOVATIONS, LLC | ILO IRP JOW | 00850001096560 |
| Therm-X | Therm-X Half-Leg Garment | ZENITH TECHNICAL INNOVATIONS, LLC | ILO IRP JOW | 00850001096348 |
| Therm-X | Therm-X Butterfly Knee Large, SPU | ZENITH TECHNICAL INNOVATIONS, LLC | ILO IRP JOW | 00850001096362 |
| Therm-X | Therm-X Butterfly Knee Large, SPU | ZENITH TECHNICAL INNOVATIONS, LLC | ILO IRP JOW | 00850001096584 |