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Zenith Technical Innovations, LLC.

United States·US-MF-000047832

Last updated June 8, 2026

Information

Country: United States
Address: 1396, St. Paul Avenue, Gurnee, United States
Website: zti1.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Rebecca Schild
EUDAMED SRN: US-MF-000047832
FDA FEI Number: —
DUNS Number: 062931546

Catalogue (33)

Device	Model / Reference	Registries	Class	Status
Therm-X	Therm-X Back Garment	FDA UDI	Class II	Active
Therm-X	Therm-X Pro	FDA UDI	Class II	Active
Therm-X	Therm-X Umbilical Hose	FDA UDI	Class II	Active
Therm-X	Therm-X Ankle SPU	FDA UDI	Class II	Active
Therm-X	Therm-X Hand SPU	FDA UDI	Class II	Active
Therm-X	Therm-X HOME	FDA UDI	Class II	Active
Therm-X	Therm-X Calf DVT Garment	FDA UDI	Class II	Active
Therm-X	Therm-X Knee SPU	FDA UDI	Class II	Active
Therm-X	Therm-X Butterfly Knee Large, SPU	FDA UDI	Class II	Active
Therm-X	Therm-X HOME	FDA UDI	Class II	Active
Therm-X	Therm-X Foot DVT Garment	FDA UDI	Class II	Active
Therm-X	Therm-X Hip SPU	FDA UDI	Class II	Active
Therm-X	Therm-X AT	FDA UDI	Class II	Active
Therm-X	Therm-X Power Supply and Cord (Medical Grade)	FDA UDI	Class II	Active
Therm-X	Therm-X AT	FDA UDI	Class II	Active
Therm-X	Therm-X Butterfly Knee Small, SPU	FDA UDI	Class II	Active
Therm-X	Therm-X Shoulder SPU	FDA UDI	Class II	Active
Therm-X	Therm-X Back SPU	FDA UDI	Class II	Active
Therm-X	Therm-X Disposable Calf DVT Garment	FDA UDI	Class II	Active
Therm-X Garment - Knee	TX0102	EUDAMEDFDA UDI	Class I	Active
Therm-X Garment Extender Straps	TX0109	EUDAMEDFDA UDI	Class I	Active
Therm-X Pro, Therm-X AT, Therm-X Pro Athlete	K181149	FDA 510(k)	Class II	Active
Therm-X (Home); Therm-X (AT)	K240125	FDA 510(k)	Class II	Active
Therm-X Garment - Ankle	TX0104	EUDAMEDFDA UDI	Class I	Active
Therm-X Garment - Half Leg	TX0111	EUDAMEDFDA UDI	Class I	Active
Therm-X Garment - Back	Z120616	EUDAMED	Class I	Active
Therm-X Split Hose	TX0208	EUDAMEDFDA UDI	Class I	Active
Therm-X AT	TX0002	EUDAMED	Class IIa	Active
Therm-X Garment - Shoulder	TX0101	EUDAMEDFDA UDI	Class I	Active
Therm-X Garment - Elbow	TX0103	EUDAMEDFDA UDI	Class I	Active
Therm-X Garment - Hip	TX0108	EUDAMEDFDA UDI	Class I	Active
Therm-X Garment - XL Shoulder	TX0110	EUDAMEDFDA UDI	Class I	Active
Therm-X Garment - Hand	TX0112	EUDAMEDFDA UDI	Class I	Active

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